Clinical Research

RTOG 0418

Title:

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma

Eligibility:

Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or laparoscopic-assisted vaginal hysterectomy) for carcinoma of the cervix or endometrium within 7 weeks prior to study entry. Patients with endometrial carcinoma must also have had a bilateral salpingo-oophorectomy. Patients must require postoperative radiation therapy (endometrial cancer) or chemo/radiation therapy (cervical cancer). Endometrial Cancer patients with stage IB, grade 3, IC grade 1-3, IIA or IIB requiring post-operative pelvic radiation therapy are eligible for this trial. Patients with unstaged (no lymph node dissection or sampling) Stage IB, grade 2 are eligible for this trial. Patients with Stage IIIC, pelvic lymph node positive only, para-aortic nodes sampled and negative and not going to receive chemotherapy are eligible for this trial. Cervical Cancer patients initially treated with a radical hysterectomy and lymph node dissection that require post-operative pelvic radiation therapy are eligible for this trial. Cervical cancer patients treated with a simple hysterectomy with negative margins and negative nodes by CT/MRI/PET-CT are eligible for this trial. Cervical cancer patients: post-radical hysterectomy - if the patient has positive pelvic nodes (negative para-aortic nodes); post-radical hysterectomy - if the patient has microscopic parametrial invasion and negative margins; and post-radical hysterectomy - if the patient qualifies by having met the Sedlis criteria for post-surgery for pelvic radiation therapy are eligible for this study. The patient must have two of the following risk factors for this criterion: 1/3 or more stromal invasion; lymph-vascular space invasion; large clinical tumor diameter (> 4 cm); Age > 18; Zubrod performance status 0-2; Patients with adequate bone marrow, renal and hepatic function (all labs are to be obtained < 14 days prior to registration): Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other interventions to achieve Hg > 8.0 g/dl is acceptable.) (Endometrial and cervix patients); WBC > 4,000/mm3 (Cervix patients only);ANC > 1,800 cells/mm3 (Cervix patients only); Platelets > 100,000 cells/mm3(Cervix patients only); Serum Creatinine < 2.0 mg/dl and calculated creatinine clearance > 50 cc/min (Cervix patients only); AST < 2 x ULN (Cervix patients only); Bilirubin < 2 x ULN (Cervix patients only); Alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded (Cervix patients only). Prior to registration CT/MRI/PET-CT of abdomen/pelvis, for initial radiological staging, must be performed pre- or post-surgery (Cervix patients only). Chest x-ray or chest CT must be performed within 8 weeks prior to study entry. The patient must sign a study-specific informed consent.

Treatment :

Study size: 92

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