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Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
Sponsor: Tata Memorial Centre
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-05-29
Completion Date
2029-05-25
Last Updated
2025-04-15
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated 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.
Cisplatin
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.
Vaginal 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