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

Korábbi kezelés

• Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
• Patients with cervix cancer who have received any previous radiation or chemotherapy
• Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)

Más betegség

• Patients with septicemia or severe infection
• Patients with intestinal obstruction or gastrointestinal bleeding
• Patients with postoperative fistula
• 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

Egyéb

• Patients whose circumstances do not permit completion of the study or the required follow-up
• Patients with GOG performance status of 3 or 4

• 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