Intensity Modulated Radiation Therapy in Treating Patients with Cervical Cancers

Status: Active

Description

This randomized phase II / III trial studies how well intensity modulated radiation therapy (IMRT) works and compares it to conventional radiation therapy in treating patients with cervical cancers. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether IMRT is more effective than conventional radiation therapy in treating cervical cancers.

Eligibility Criteria

Inclusion Criteria

  • Biopsy-proven, unresected stage IB-IVA invasive carcinoma of the cervix
  • Candidate for pelvic or pelvic-inguinal radiotherapy and concurrent chemotherapy; patients undergoing preoperative chemoradiotherapy are excluded
  • Able to undergo diagnostic PET/computed tomography (CT) or PET/CT simulation
  • History/physical examination within 42 days prior to registration to document cervical tumor size and stage
  • CT, magnetic resonance imaging (MRI), or PET/CT imaging of the chest, abdomen, and pelvic regions within 42 days prior to registration (for stage I patients, posterior-anterior [PA] and lateral chest x-ray is sufficient for chest imaging)
  • Karnofsky performance status 60-100
  • Absolute neutrophil count (ANC) >= 1500 cells/mm^3 (to be obtained =< 28 days prior to registration on study)
  • Platelets >= 100,000 cells/mm^3 (to be obtained =< 28 days prior to registration on study)
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) (to be obtained =< 28 days prior to registration on study)
  • Creatinine clearance >= 50 mg/dl OR serum creatinine =< 1.5 x upper limit of normal (ULN) (to be obtained =< 28 days prior to registration on study)
  • Bilirubin < 1.5 mg/dl (to be obtained =< 28 days prior to registration on study)
  • White blood cells (WBC) >= 3,000/ul (to be obtained =< 28 days prior to registration on study)
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 3 x ULN (to be obtained =< 28 days prior to registration on study)
  • Negative pregnancy test for women of child-bearing potential (to be obtained =< 28 days prior to registration on study)
  • Women of childbearing potential must agree to practice effective birth control throughout their participation in the treatment phase of the study
  • If there is clinical suspicion of acquired immune deficiency syndrome (AIDS), a human immunodeficiency virus (HIV) test must be done within 42 days prior to registration; note: HIV positive patients with a cluster of differentiation (CD)4+ T cell count > 200 per uL of blood and > 14% of all lymphocytes are eligible for this trial
  • Patients must sign informed consent prior to study entry

Exclusion Criteria

  • Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
  • Prior systemic chemotherapy
  • Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields
  • Para-aortic or inguinal metastasis
  • Distant metastasis
  • Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patient’s physicians requires an immediate change in management; a patient may be considered eligible for the study if the physician managing the patient’s diabetes considers that the appropriate changes in management have resulted in adequate control * Uncompensated heart disease or uncontrolled high blood pressure, which in the opinion of any of patient’s physicians, requires immediate change in management; a patient may be considered eligible for the study if the physician managing the patient’s heart disease or blood pressure considers that the appropriate changes in management have resulted in adequate control * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; patients with AIDS will be ineligible for this protocol; patients with clinical suspicion of AIDS and who are unwilling to have an HIV test are not eligible for this trial * Uncontrolled infection * Other immunocompromised status (e.g., organ transplant or chronic glucocorticoid use, or any other immunocompromised status that in the opinion of the investigator would preclude the patient from receiving protocol therapy)
  • Women who are pregnant or lactating are ineligible due to teratogenic effects on developing fetuses; women who are of child-bearing potential need to practice effective methods of contraception including oral contraceptives, intrauterine device, diaphragm with spermicides, and/or abstinence
  • Prior history of hip, pelvic, or lumbosacral prosthesis or other implanted device
  • Patients undergoing preoperative chemoradiotherapy

Locations & Contacts

California

San Diego
University of California San Diego
Status: Active
Contact: Loren K. Mell
Phone: 858-822-6040
Email: lmell@ucsd.edu

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Lorraine Portelance
Email: lportelance@med.miami.edu

China

Xi'an
Xi'an Jiaotong University College of Medicine
Status: Active
Contact: Liu Zi
Phone: 86-18991232167
Email: 18991232167@189.cn
Xijing Hospital
Status: Active
Contact: Mei Shi
Phone: 86-29-84775425
Email: mshi82@fmmu.edu.cn

Czech Republic

Hradec Kralove
University Hospital Hradec Kralove
Status: Active
Contact: Igor Sirak
Phone: 00420 495 832 176
Email: igor.sirak@seznam.cz

India

Mumbai
Tata Memorial Hospital
Status: Active
Contact: Umesh Mahantshetty
Phone: 91-22-2417-7163
Email: drumeshm@gmail.com

Poland

Krakow
The Maria Sklodowska C.M.C.C.I.O Krakow
Status: Active
Contact: Rafal Tarnawski
Phone: 48-32-278-98-12
Email: rafaltarnawski@gmail.com

Thailand

Bangkok
King Chulalongkorn University
Status: Active
Contact: Chonlakiet Khorprasert
Email: chonlakiet@gmail.com

United Kingdom

Guildford
Royal Surrey County Hospital
Status: Active
Contact: Alexandra Stewart
Phone: 01483 571122
Email: Alexandra.Stewart@nhs.net

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To test whether image-guided (IG)-bone marrow sparing (BMS)-IMRT improves progression-free survival (PFS) for cervical cancer patients treated with concurrent chemotherapy.

SECONDARY OBJECTIVES:

I. To compare acute and long-term quality of life (QOL) in the study arms.

II. To compare acute and late hematologic and gastrointestinal (GI) toxicity in the study arms.

III. To compare total chemotherapy dose delivered in the study arms.

IV. To compare locoregional (pelvic) failure, distant metastasis, and overall survival in the study arms.

V. To evaluate the quality of IMRT planning in the international cooperative group setting.

VI. To quantify changes in tumor cellularity using restriction spectrum imaging (RSI substudy).

VII. To compare hematologic toxicity of fluorothymidine F-18 (FLT)-positron emission tomography (PET)-based IG-BMS-IMRT vs. other treatment approaches (fludeoxyglucose [FDG]-PET-based IG-BMS-IMRT and standard radiotherapy).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo image-guided bone marrow sparing IMRT daily up to 5.5 weeks and receive cisplatin intravenously (IV) weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo conventional radiation therapy daily up to 5.5 weeks and receive cisplatin IV weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3-4, 6, 12, 24, and 36 months.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
University of California San Diego

Principal Investigator
Loren K. Mell

Trial IDs

Primary ID 110808
Secondary IDs NCI-2012-02858
Clinicaltrials.gov ID NCT01554397