Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Biomarker/Laboratory analysis, Supportive care, Treatment | Active | 18 and over | NCI, Other | CDR0000654709 RTOG-0724, NCT00980954 |
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Further Study Information
OBJECTIVES:
Primary
- To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.
Secondary
- To evaluate adverse events.
- To evaluate overall survival.
- To evaluate quality of life.
- To evaluate chemotherapy-induced neuropathy.
- To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy with respect to toxicity and local control.
- To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.
- To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify SNPs in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs yes), radiotherapy modality (standard external beam radiotherapy [EBRT] vs intensity-modulated radiotherapy [IMRT]), and radiotherapy dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.
NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.
- Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed by the FACT-GOG/NTX4, FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.
Blood and tissue samples may be collected for gene expression analysis by IHC and for biomarker and polymorphism studies.
After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
- Positive pelvic nodes
- Positive parametrium
- Positive para-aortic nodes that have been completely resected and are PET/CT scan-negative
- PET only required if positive para-aortic nodes during surgery
- Clinical stage IA2, IB, or IIA disease (this corresponds to surgical TNM staging of T1-T2, N1, M0)
- Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
- Para-aortic and pelvic node sampling required
- If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required
- A negative pre- or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection
- No gross residual disease
- No neuroendocrine histology
- No distant metastases
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC ≥ 1,800/mm³
- Platelets ≥ 100,000/mm³
- WBC ≥ 4,000/mm³
- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
- Serum creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 1.5 times upper limit of normal
- ALT and/or AST normal
- Alkaline phosphatase normal
- Known HIV positivity allowed provided CD4 count is ≥ 350/mm³ within the past 14 days
- No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
- No severe, active co-morbidity, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
- Coagulation defects
- No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy for the current cervical cancer
- Prior chemotherapy for a different cancer is allowed
- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology Group
National Cancer Institute| Anuja Jhingran |  | Principal Investigator |
Trial Sites
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| U.S.A. | |||
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| Arizona | |||
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| Peoria | |||
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| Arizona Center for Cancer Care - Peoria | |||
| Christopher A Biggs | Ph: 623-773-2873 | ||
| California | |||
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| Burbank | |||
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| Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | |||
| Rex Hoffman | Ph: 818-847-3220 | ||
| Orange | |||
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| St. Joseph Hospital Regional Cancer Center - Orange | |||
| Krishnansu S Tewari | Ph: 714-456-6191 | ||
| Email: awallick@uci.edu | |||
| Pomona | |||
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| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | |||
| Yallapragada S. Rao | Ph: 909-865-9555 | ||
| Sacramento | |||
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| Mercy General Hospital | |||
| Christopher Jones | Ph: 916-646-8300 | ||
| Radiological Associates of Sacramento Medical Group, Incorporated | |||
| Christopher Jones | Ph: 916-646-8300 | ||
| Saint Helena | |||
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| Saint Helena Hospital | |||
| David J Tate | Ph: 707-967-3698 | ||
| Colorado | |||
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| Aurora | |||
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| University of Colorado Cancer Center at UC Health Sciences Center | |||
| Tracey E Schefter | Ph: 720-848-0650 | ||
| Colorado Springs | |||
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| Penrose Cancer Center at Penrose Hospital | |||
| Anuj Peddada | Ph: 888-785-6789 | ||
| Connecticut | |||
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| New Britain | |||
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| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |||
| Neal B Goldberg | Ph: 860-224-5660 | ||
| Florida | |||
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| Orlando | |||
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| Florida Hospital Cancer Institute at Florida Hospital Orlando | |||
| Robert J Sollaccio | Ph: 407-303-5623 | ||
| Georgia | |||
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| Atlanta | |||
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| Northside Hospital Cancer Center | |||
| Henry D Cline | Ph: 404-303-3355 | ||
| Savannah | |||
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| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |||
| James J Burke | Ph: 912-350-8568 | ||
| Idaho | |||
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| Boise | |||
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| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | |||
| Samir Narayan | Ph: 734-712-3456 | ||
| Illinois | |||
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| Chicago | |||
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| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |||
| William Small | Ph: 312-695-1301 | ||
| Email: cancer@northwestern.edu | |||
| Rush Cancer Institute at Rush University Medical Center | |||
| Krystyna D. Kiel | Ph: 312-942-5498 | ||
| Email: clinical_trials@rush.edu | |||
| Peoria | |||
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| OSF St. Francis Medical Center | |||
| John W. Kugler | Ph: 800-793-2262 | ||
| Indiana | |||
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| Anderson | |||
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| Saint John's Health System | |||
| Alexander M. Yeh | Ph: 765-646-8358 | ||
| Beech Grove | |||
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| St. Francis Hospital and Health Centers - Beech Grove Campus | |||
| David H Moore | Ph: 317-851-2555 | ||
| Indianapolis | |||
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| St. Francis Hospital Cancer Care Services | |||
| David H Moore | Ph: 317-851-2555 | ||
| Mishawaka | |||
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| Michiana Hematology-Oncology, PC - Mishawaka | |||
| David A. Hornback | Ph: 800-284-7370 | ||
| Iowa | |||
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| Iowa City | |||
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| Holden Comprehensive Cancer Center at University of Iowa | |||
| Mark C Smith | Ph: 800-237-1225 | ||
| Mason City | |||
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| Mercy Cancer Center at Mercy Medical Center - North Iowa | |||
| Arvind Y Vemula | Ph: 800-433-3883 | ||
| Kansas | |||
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| Overland Park | |||
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| Kansas City Cancer Centers - Southwest | |||
| Parvesh Kumar | Ph: 913-588-4709 | ||
| Wichita | |||
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| Via Christi Cancer Center at Via Christi Regional Medical Center | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Maryland | |||
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| Baltimore | |||
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| Greater Baltimore Medical Center Cancer Center | |||
| Paul Celano | Ph: 443-849-3706 | ||
| Michigan | |||
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| Adrian | |||
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| Hickman Cancer Center at Bixby Medical Center | |||
| Rex B Mowat | Ph: 517-265-0116 | ||
| Detroit | |||
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| Van Elslander Cancer Center at St. John Hospital and Medical Center | |||
| Samir Narayan | Ph: 734-712-3456 | ||
| Wayne State University | |||
| Steven R. Miller | Ph: 313-576-9363 | ||
| Kalamazoo | |||
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| West Michigan Cancer Center | |||
| Raymond Sterling Lord | Ph: 269-373-7458 | ||
| Port Huron | |||
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| Mercy Regional Cancer Center at Mercy Hospital | |||
| Samir Narayan | Ph: 734-712-3456 | ||
| Warren | |||
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| St. John Macomb Hospital | |||
| Samir Narayan | Ph: 734-712-3456 | ||
| Minnesota | |||
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| Rochester | |||
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| Mayo Clinic Cancer Center | |||
| Ivy A. Petersen | Ph: 507-538-7623 | ||
| Mississippi | |||
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| Jackson | |||
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| University of Mississippi Cancer Clinic | |||
| James Tate Thigpen | Ph: 601-815-6700 | ||
| Missouri | |||
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| Kansas City | |||
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| Kansas City Cancer Centers - North | |||
| Parvesh Kumar | Ph: 913-588-4709 | ||
| Kansas City Cancer Centers - South | |||
| Parvesh Kumar | Ph: 913-588-4709 | ||
| Saint Louis | |||
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| David C. Pratt Cancer Center at St. John's Mercy | |||
| Bethany G. Sleckman | Ph: 913-948-5588 | ||
| Springfield | |||
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| Hulston Cancer Center at Cox Medical Center South | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| St. John's Regional Health Center | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| Nebraska | |||
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| Omaha | |||
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| Methodist Estabrook Cancer Center | |||
| Tien-Shew W Huang | Ph: 402-354-5144 | ||
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |||
| Andrew O Wahl | Ph: 800-999-5465 | ||
| New Hampshire | |||
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| Manchester | |||
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| Elliot Regional Cancer Center at Elliot Hospital | |||
| Brian R Knab | Ph: 603-663-1800 | ||
| New Jersey | |||
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| Camden | |||
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| Cancer Institute of New Jersey at Cooper University Hospital - Camden | |||
| Tamara A LaCouture | Ph: 856-325-6757 | ||
| Morristown | |||
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| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |||
| Yana P Goldberg | Ph: 973-971-5900 | ||
| Mount Holly | |||
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| Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County | |||
| Lemuel S. Ariaratnam | Ph: 888-847-8823 | ||
| Newark | |||
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| UMDNJ University Hospital | |||
| A. Dolly Razdan | Ph: 732-235-8675 | ||
| Voorhees | |||
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| Cancer Institute of New Jersey at Cooper - Voorhees | |||
| Tamara A LaCouture | Ph: 856-325-6757 | ||
| New York | |||
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| Bronx | |||
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| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |||
| Mark H. Einstein | Ph: 718-904-2730 | ||
| Email: aecc@aecom.yu.edu | |||
| Brooklyn | |||
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| SUNY Downstate Medical Center | |||
| Marvin Rotman | Ph: 718-270-8216 | ||
| Email: sima.terebelo@downstate.edu | |||
| New York | |||
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| Memorial Sloan-Kettering Cancer Center | |||
| Mario M Leitao | Ph: 212-639-7202 | ||
| Rochester | |||
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| Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester | |||
| Yuhchyau Chen | Ph: 585-275-5830 | ||
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |||
| Yuhchyau Chen | Ph: 585-275-5830 | ||
| North Carolina | |||
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| Charlotte | |||
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| Blumenthal Cancer Center at Carolinas Medical Center | |||
| Robert Victor Higgins | Ph: 704-355-2884 | ||
| Ohio | |||
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| Akron | |||
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| McDowell Cancer Center at Akron General Medical Center | |||
| Mitchell Lee Fromm | Ph: 330-344-6348 | ||
| Summa Center for Cancer Care at Akron City Hospital | |||
| Charles A Kunos | Ph: 800-641-2422 | ||
| Barberton | |||
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| Barberton Citizens Hospital | |||
| Charles A Kunos | Ph: 800-641-2422 | ||
| Cincinnati | |||
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| University of Cincinnati | |||
| Thomas J. Reid | Ph: 937-298-3399 | ||
| Email: uchealthnews@uc.edu | |||
| Cleveland | |||
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| Case Comprehensive Cancer Center | |||
| Rodney Ellis | Ph: 800-641-2422 | ||
| Columbus | |||
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| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |||
| Nina A Mayr | Ph: 866-627-7616 | ||
| Email: osu@emergingmed.com | |||
| Orange Village | |||
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| UHHS Chagrin Highlands Medical Center | |||
| Steven E. Waggoner | Ph: 800-641-2422 | ||
| Ravenna | |||
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| Robinson Radiation Oncology | |||
| Mitchell Lee Fromm | Ph: 330-344-6348 | ||
| Salem | |||
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| Cancer Care Center, Incorporated | |||
| William F. Demas | Ph: 330-615-4132 | ||
| Sandusky | |||
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| University Hospitals Ireland Cancer Center at Firelands Regional Medical Center | |||
| Rodney Ellis | Ph: 800-641-2422 | ||
| Sylvania | |||
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| Flower Hospital Cancer Center | |||
| Rex B Mowat | Ph: 517-265-0116 | ||
| Wooster | |||
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| Cancer Treatment Center | |||
| William F. Demas | Ph: 330-615-4132 | ||
| Oklahoma | |||
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| Oklahoma City | |||
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| Oklahoma University Cancer Institute | |||
| Terence S. Herman | Ph: 405-271-4272 | ||
| Email: julie-traylor@ouhsc.edu | |||
| Tulsa | |||
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| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |||
| Charles E Stewart | Ph: 918-494-2200 | ||
| Pennsylvania | |||
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| West Reading | |||
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| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | |||
| Albert Yuen | Ph: 610-988-9323 | ||
| Wynnewood | |||
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| Lankenau Cancer Center at Lankenau Hospital | |||
| Paul B. Gilman | Ph: 484-476-2649 | ||
| Email: wellenbachj@mlhs.org | |||
| Rhode Island | |||
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| Providence | |||
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| Women and Infants Hospital of Rhode Island | |||
| Carolyn K McCourt | Ph: 401-274-1122 | ||
| South Dakota | |||
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| Rapid City | |||
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| Rapid City Regional Hospital | |||
| Michael J Swartz | Ph: 605-716-3982 | ||
| Email: research@rcrh.org | |||
| Sioux Falls | |||
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| Sanford Cancer Center at Sanford USD Medical Center | |||
| Miroslaw A Mazurczak | Ph: 605-328-1367 | ||
| Texas | |||
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| Dallas | |||
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| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |||
| David Scott Miller | Ph: 214-648-7097 | ||
| Houston | |||
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| M. D. Anderson Cancer Center at University of Texas | |||
| Ann H Klopp | |||
| Email: aklopp@mdanderson.org | |||
| Methodist Hospital | |||
| Aparna A Kamat | Ph: 281-277-5200 | ||
| Univeristy of Texas M.D. Anderson Cancer Center | |||
| Ann H Klopp | Ph: 713-792-3245 | ||
| Utah | |||
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| Murray | |||
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| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | |||
| R. Jeffrey Lee | Ph: 801-507-3950 | ||
| Ogden | |||
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| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | |||
| R. Jeffrey Lee | Ph: 801-507-3950 | ||
| Saint George | |||
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| Dixie Regional Medical Center - East Campus | |||
| R. Jeffrey Lee | Ph: 801-507-3950 | ||
| Salt Lake City | |||
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| Huntsman Cancer Institute at University of Utah | |||
| Matthew M Poppe | Ph: 801-581-4477 | ||
| Email: clinical.trials@hci.utah.edu | |||
| Washington | |||
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| Seattle | |||
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| Seattle Cancer Care Alliance | |||
| Benjamin E. Greer | Ph: 206-616-8289 | ||
| Yakima | |||
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| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | |||
| Sean F. Cleary | Ph: 877-902-3324 | ||
| West Virginia | |||
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| Wheeling | |||
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| Schiffler Cancer Center at Wheeling Hospital | |||
| Jon David Pollock | Ph: 304-243-6442 | ||
| Wisconsin | |||
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| Green Bay | |||
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| St. Vincent Hospital Regional Cancer Center | |||
| Gregory M. Cooley | Ph: 920-433-8889 | ||
| Milwaukee | |||
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| Froedtert Hospital and Medical College of Wisconsin | |||
| Beth Ann Erickson | Ph: 414-805-4380 | ||
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |||
| Scott A Kamelle | Ph: 414-649-7200 | ||
| West Allis | |||
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| Aurora Women's Pavilion of West Allis Memorial Hospital | |||
| Peter Johnson | Ph: 800-252-2990 | ||
| Canada | |||
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| Quebec | |||
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| Montreal | |||
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| McGill Cancer Centre at McGill University | |||
| Luis Souhami | Ph: 514-934-1934ext42953 | ||
| Email: evelyn.ortega@muhc.mcgill.ca | |||
| China | |||
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| Chai Wan | |||
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| Pamela Youde Nethersole Eastern Hospital | |||
| Inda Sung Soong | Ph: 215-574-3173 | ||
| Republic of Korea | |||
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| Kyeonggi-do | |||
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| Seongnam City | |||
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| Seoul National University Bundang Hospital | |||
| Kidong Kim | Ph: 011-82-02-9702-114 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00980954
Information obtained from ClinicalTrials.gov on November 20, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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