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Phase III Randomized Comparison of Radiotherapy with vs without Continuous-Infusion 5-FU/Bolus CDDP Following Radical Hysterectomy and Node Dissection in High-Risk Patients with Stages IA2, IB, and IIA Carcinoma of the Cervix

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageNCISWOG-8797
GOG-109, RTOG-9112, INT-0107

Objectives

I.  Compare survival, progression-free survival, and failure rate outside the 
pelvis of patients with Stages IA2, IB, or IIA carcinoma of the cervix with 
risk factors (positive pelvic nodes, parametrial involvement, or positive 
surgical margins) randomly assigned following radical hysterectomy to 
radiotherapy with vs. without fluorouracil/cisplatin.

II.  Compare the toxicities associated with these 2 regimens.

Entry Criteria

Disease Characteristics:


Primary, histologically confirmed invasive squamous cell carcinoma,
adenocarcinoma, or adenosquamous carcinoma of the uterine cervix

Clinical Stage IA2/IB/IIA disease required

Prior radical hysterectomy with total pelvic lymphadenectomy with, at surgical
evaluation, at least 1 of the following:
  Positive pelvic lymph nodes
  Parametrial involvement
  Positive surgical margins

Pathologically confirmed para-aortic lymph nodes required
  Para-aortic nodes not separately sampled allowed if common iliac nodes
     negative
  Positive common iliac nodes allowed if para-aortic nodes negative
  No unresectable nodal disease


Prior/Concurrent Therapy:


Biologic therapy:
  No prior immunotherapy (including biologics)

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  No prior hormonal cancer therapy allowed

Radiotherapy:
  No prior pelvic irradiation

Surgery:
  Radical hysterectomy with pelvic lymphadenectomy and para-aortic node
  sampling required within 6 weeks of registration


Patient Characteristics:


Age:
  Any age

Performance status:
  SWOG 0-2

Hematopoietic:
  WBC at least 3,000
  Platelets at least 100,000

Hepatic:
  Bilirubin within ULN

Renal:
  No "horseshoe kidney" detected by CT, sonogram, or IVP
  Creatinine within ULN

Other:
  Capable of beginning therapy within 5 working days of registration
  No history of severe pelvic inflammatory disease defined as 1 or more of the
     following:
        Requiring surgical drainage
        Requiring hysterectomy/salpingo-oophorectomy
        Inducing sterility
        Producing symptomatic sequelae
  No sepsis or grade 3 or worse infection
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Curatively-treated Stage I cervical carcinoma

Blood/body fluid analyses to determine eligibility and imaging studies and
physical exams for tumor measurement completed within 14 days prior to
registration; screening exams other than blood/body fluid analyses and imaging
studies of nonmeasurable disease or uninvolved organs completed within 42 days
prior to registration


Expected Enrollment

240 patients will be randomized over 5.5 years.

Outline

Randomized study.

Arm I:  Radiotherapy plus 2-Drug Combination Chemotherapy.  Pelvic irradiation 
with x-ray beams of at least 4 MV; plus Fluorouracil, 5-FU, NSC-19893; 
Cisplatin, CDDP, NSC-119875.

Arm II:  Radiotherapy.  Pelvic irradiation as in Arm I.

Published Results

Liao SY, Darcy KM, Randall LM, et al.: Prognostic relevance of carbonic anhydrase-IX in high-risk, early-stage cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 116 (3): 452-8, 2010.[PUBMED Abstract]

Randall LM, Monk BJ, Darcy KM, et al.: Markers of angiogenesis in high-risk, early-stage cervical cancer: A Gynecologic Oncology Group study. Gynecol Oncol 112 (3): 583-9, 2009.[PUBMED Abstract]

Monk BJ, Wang J, Im S, et al.: Rethinking the use of radiation and chemotherapy after radical hysterectomy: a clinical-pathologic analysis of a Gynecologic Oncology Group/Southwest Oncology Group/Radiation Therapy Oncology Group trial. Gynecol Oncol 96 (3): 721-8, 2005.[PUBMED Abstract]

Im SS, Monk BJ, Wang J, et al.: Rethinking the use of chemotherapy and radiation after radical hysterectomy: a clinical-pathologic analysis of SWOG 8797/GOG 109. [Abstract] Gynecol Oncol 92: A-8, 396, 2004.

Peters WA 3rd, Liu PY, Barrett RJ 2nd, et al.: Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 18 (8): 1606-13, 2000.[PUBMED Abstract]

Peters WA, Liu PY, Barrett R, et al.: Cisplatin, 5-fluorouracil plus radiation therapy are superior to radiation therapy as adjunctive therapy in high-risk, early stage carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: report of a phase III intergroup study. [Abstract] Proceedings of the Society of Gynecologic Oncologists A1, 1999.

Related Publications

Gold M, Smith C, Hyde J Jr, et al.: High risk early stage cervical cancer following radical hysterectomy: chemoradiation with weekly cisplatin or cisplatin/5-FU per GOG 109? [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-68, 2006.

Monaghan J: Time to add chemotherapy to radiotherapy for cervical cancer. Lancet 353 (9161): 1288-9, 1999.[PUBMED Abstract]

Rose PG, Bundy BN, Watkins EB, et al.: Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med 340 (15): 1144-53, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

William Peters, MD, Protocol chair
Ph: 206-215-3200

Gynecologic Oncology Group

Rolland Barrett, MD, Protocol chair
Ph: 336-277-8800
Email: rbarrett@phoa.org

Radiation Therapy Oncology Group

Perry Grigsby, MD, Protocol chair
Ph: 314-362-8502; 800-600-3606
Email: pgrigsbyp@wustl.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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