Postoperative hypofractionated radiation for cervical and endometrial cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II prospective study aims to evaluate the late effects of hypofractionated external radiation therapy in patients with early-stage cervical and endometrial cancers requiring postoperative treatment. Patients will receive a total dose of 39 Gray (Gy) in 13 fractions using intensity-modulated radiotherapy (IMRT) over 2.5 to 3 weeks, with some receiving concurrent cisplatin chemotherapy. Additionally, vaginal brachytherapy will be administered to certain patients after external beam radiation. The study will monitor treatment-related toxicities and quality of life at specified intervals.

Why it matters

Who can join: the full rules

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)

Where it's running

• Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
  Navi Mumbai, Maharahstra, India Recruiting
• Tata Memorial Hospital
  Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Dr. Prachi D Mittal, MD — Tata Memorial Hospital
• Study coordinator: Dr. Prachi D Mittal, MD
• Email: mittalprachi@gmail.com
• Phone: +91 9004938871

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.