Adult Clinical Trials:GYNECOLOGICAL

RTOG 0418: GYNECOLOGIC

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

• 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.
• 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 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.

Treatment
1.  Endometrial cancer patients: IMRT 28 fractions over 5.5 weeks.
2.    Cervical cancer patients: IMRT 28 fractions over 5.5 weeks and concurrent cisplatin starting on a Monday or a Tuesday for 5 cycles