Postoperative hypofractionated radiation for cervical and endometrial cancers
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
This study is testing a new type of radiation treatment after surgery for early-stage cervical and endometrial cancers to see how it affects patients' health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Navi Mumbai, Maharahstra and 1 other locations) |
| Trial ID | NCT05857631 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed cervical or endometrial cancer post-hysterectomy who require adjuvant pelvic radiation.
Not a fit: Patients with macroscopic residual disease or those requiring extended field radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce late gastrointestinal and genitourinary toxicities associated with postoperative radiation therapy.
How similar studies have performed: Other studies have shown promise with hypofractionated radiation approaches, but this specific methodology is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Navi Mumbai, Maharahstra and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.