Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


SCCA Gynecologic Cancer Clinical Trials

Radiation Therapy Stage I or Stage II Cervical Cancer Post Surgery (GOG 0263)
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
Status Conditions Phase Study ID
Recruiting Cervical Cancer Phase III GOG 0263
NCT01101451
Summary

RATIONALE: 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 or by stopping them from dividing. 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.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery.


Investigator
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

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
September 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.