Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)
This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
PRIMARY OBJECTIVE:
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE).
III. To provide assessment of patient risk version (vs) benefit (positive study only).
QUALITY OF LIFE OBJECTIVE:
I. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events).
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone.
II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.
ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Inclusion Criteria:
Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
Positive capillary-lymphovascular space involvement and one of the following:
Negative capillary-lymphatic space involvement
Absolute neutrophil count (ANC) >= 1,500/mcl
Platelets >= 100,000/mcl
Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min
Bilirubin =< 1.5 x normal
Alkaline phosphate =< 3 x normal
Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal
Gynecologic Oncology Group (GOG) performance status 0, 1, 2
Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
Patients who have met the pre-entry requirements
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Sylmar, California 91342, United States
Vacaville, California 95687, United States
Deerfield Beach, Florida 33442, United States
Miami, Florida 33136, United States
Pekin, Illinois 61554, United States
East China Township, Michigan 48054, United States
Grosse Pointe Woods, Michigan 48236, United States
Macomb, Michigan 48044, United States
Norton Shores, Michigan 49444, United States
Rochester Hills, Michigan 48309, United States
Warren, Michigan 48093, United States
West Branch, Michigan 48661, United States
American Fork, Utah 84003, United States
Spokane, Washington 99204, United States
Spokane, Washington 99218, United States
Spokane Valley, Washington 99216, United States
Yakima, Washington 98902, United States
Summit, Wisconsin 53066, United States
Shiwa-gun, Iwate 028-3695, Japan
Dalseo-gu, Daegu 42601, South Korea
Jung-gu, Incheon 400-711, South Korea