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โ† Trials
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Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study

RecruitingNAAges 18 Years - 80 YearsFemaleTata Memorial Centre
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 ยฑ 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)
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What it tests

  • Hypofractionated Image guided External Beam Radiation Therapy (EBRT)
  • Cisplatin
  • Vaginal brachytherapy
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Where

2 sites
Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
Navi Mumbai, India
Tata Memorial Hospital
Mumbai, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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