RecruitingNot ApplicableNCT05857631

Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study


Sponsor

Tata Memorial Centre

Enrollment

90 participants

Start Date

May 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a shorter, higher-dose radiation schedule (hypofractionation — fewer sessions with larger doses per session) after hysterectomy is as safe and effective as the standard longer radiation schedule for women with cervical or endometrial (uterine) cancer. **You may be eligible if...** - You have been diagnosed with cervical or endometrial cancer and have had a hysterectomy - Your doctors have recommended radiation therapy to the pelvis after surgery - Your cancer had intermediate or high-risk features that make radiation necessary - You are in generally good health (ECOG 0–2) **You may NOT be eligible if...** - You have visible remaining cancer after surgery - You need radiation that extends to the lymph nodes near the aorta (para-aortic region) - You have HIV - You have had pelvic radiation before - You have a prior cancer treated with chemotherapy - You have pre-existing bowel or bladder conditions that would make it hard to assess side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated Image guided External Beam Radiation Therapy (EBRT)

External beam radiotherapy to pelvis: Post operative hypofractionated external beam radiotherapy with intensity modulated/arc technique, to a dose of 39 Gy in 13 fractions, at 3 Gy per fraction, delivered once daily, 5 days a week, over 2.5-3 weeks.

DRUGCisplatin

Patients who require adjuvant chemotherapy along with radiation, based on predefined risk features, will receive 5 cycles of cisplatin on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT.

RADIATIONVaginal brachytherapy

Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.


Locations(2)

Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

Navi Mumbai, Maharahstra, India

Tata Memorial Hospital

Mumbai, Maharashtra, India

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NCT05857631


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