NCT05857631Recruiting
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 30 Mar 2023
- Start date
- 29 May 2023
- Primary completion date
- 25 May 2029
- Lead sponsor
- Tata Memorial Centre
- Diseases
- Endometrial cancer, Cervical cancer
- NCT number
- NCT05857631
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 29 May 2023 to the primary completion date, 25 May 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with pelvic radiation previously
Other illness
- 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 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Coordinator of this site? Confirm its status | Navi Mumbai | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.