Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery

Completed · Phase 3

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage I Cervical Cancer AJCC v6 and v7, Stage IA Cervical Cancer AJCC v6 and v7, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7

In brief

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.

Key facts

Study ID

NCT01101451

Run by

GOG Foundation

People needed

340

Starts

2010-04-12

Expected to finish

2024-04-02

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Deep third penetration
• Middle third penetration, clinical tumor >= 2 cm
• Superficial third penetration, clinical tumor >= 5 cm
• Negative capillary-lymphatic space involvement
• Middle or deep third penetration, clinical tumor >= 4 cm
• 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

You may not qualify if…

• Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
• Patients with septicemia or severe infection
• Patients with intestinal obstruction or gastrointestinal bleeding
• Patients with postoperative fistula
• Patients with cervix cancer who have received any previous radiation or chemotherapy
• Patients whose circumstances do not permit completion of the study or the required follow-up
• Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
• Patients with GOG performance status of 3 or 4
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Where it is running

• Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
• Alaska Regional Hospital — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• PCR Oncology — Arroyo Grande, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• John Muir Medical Center-Concord Campus — Concord, California, United States
• Sutter Davis Hospital — Davis, California, United States
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.