Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study

• Status: Not yet recruiting
• Trial end date: 2029-05-25
• Target enrollment: 0
• Participant gender: Female

Summary

The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Centre
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.

Exclusion Criteria:

1. Patients with macroscopic residual disease (R+ resection) postoperatively

2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)

3. Patients treated with chemotherapy for any prior malignancy at any time

4. Patients treated with pelvic radiation previously

5. Patients with human immunodeficiency virus infection

6. Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)