Last updated on March 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cervical Squamous Cell Carcinoma | Stage IIA Cervical Cancer | Not Otherwise Specified | Cervical Adenocarcinoma | Stage IA Cervical Cancer | Cervical Adenosquamous Carcinoma | Stage IB Cervical Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female

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 times normal
  • Alkaline phosphate </= 3 times normal
  • Serum glutamic oxaloacetic transaminase (SGOT) ? 3 times 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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