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)

Purpose:

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.

Study summary:

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.

Criteria:

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: - 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 Exclusion Criteria: - 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

Study is Available At:

Original ID:

GOG-0263

NCT ID:

NCT01101451

Secondary ID:

NCI-2011-02037

Study Acronym:

Brief Title:

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

Official Title:

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)

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT01101451

Overall Status:

Active, not recruiting

Study Phase:

Phase 3

Genders:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Study Source:

GOG Foundation

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

2

Number of Groups:

0

Total Enrollment:

341

Enrollment Type:

Actual

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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