Clinical Trials

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

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

Primary

- To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in patients with intermediate-risk factors stage I-IIA cervical cancer after treatment with radical hysterectomy.

Secondary

- To compare the overall survival (OS) of patients treated with these regimens.

- To assess differences in incidence and severity of regimen-attributed adverse events in these patients.

- To provide assessment of patient risk vs benefit (positive study only).

- To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.

- To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.

Tertiary

- 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 treated with these regimens.

- To bank 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 treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to capillary-lymphovascular space involvement (positive vs negative), stromal invasion (deep vs middle vs superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs GOG). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo pelvic EBRT or 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 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy (FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at baseline and periodically during study.

Tumor tissue and blood samples may be collected and banked for future biomarker and other analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- Pathologically confirmed primary cervical cancer comprising one of the following cell types:

- Squamous cell carcinoma

- Adenosquamous carcinoma

- Adenocarcinoma

- Stage I-IIA disease

- Initially treated with a standard radical hysterectomy with pelvic lymphadenectomy

- Patients with depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed must meet the following criteria:

- 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

- No patients with tumor in the parametria, pelvic lymph nodes, or any other extra-uterine site or with positive surgical margins

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphate ≤ 3 times ULN

- SGOT ≤ 3 times ULN

- No septicemia or severe infection

- No intestinal obstruction or gastrointestinal bleeding

- No post-operative fistula

- No circumstances that do not permit completion of the study or the required study follow-up

- No renal abnormalities requiring modification of radiation field (e.g., pelvic kidney or renal transplant)

- No prior malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 3 weeks but ≤ 8 weeks since surgery

- No prior radiotherapy or chemotherapy for cancer of the cervix

- No prior cancer treatment that contraindicates this protocol therapy

- No concurrent brachytherapy boost

Last updated: 03/26/2012

NCT ID:

NCT01101451