Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
Recruiting now · Not applicable
Conditions studied: Cervical Cancer, Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT05857631
- Run by
- Tata Memorial Centre
- People needed
- 90
- Starts
- 2023-05-29
- Expected to finish
- 2029-05-25
- Last updated by the study team
- 2025-04-15
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 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.
You may not qualify if…
- Patients with macroscopic residual disease (R+ resection) postoperatively
- Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)
- Patients treated with chemotherapy for any prior malignancy at any time
- Patients treated with pelvic radiation previously
- Patients with human immunodeficiency virus infection
- 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 is running
- Advanced Centre for Treatment Research and Education in Cancer (ACTREC) — Navi Mumbai, Maharahstra, India (enrolling)
- Tata Memorial Hospital — Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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