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

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.

I'M INTERESTED

This research study is led by Dr. Tashanna Myers.

Contact: Laura Sorci, 413-794-3188

Participation details:

April 12, 2010
BH17-113
Cancer-Gynecologic, Cancer
D’Amour Center for Cancer Care, 3350 Main Street, Springfield, MA

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

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 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 cervix cancer who have received any previous radiation or chemotherapy
  • Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
  • 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
Recruiting
Interventional (Clinical Trial), Randomized
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