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HYPOfractionated RadioTherapy in Cervical Cancer

Study acronym: HYPORT-CC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study title shortened, about 1 wordv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is a prospective, randomized, non-inferiority clinical trial which will test whether a short course of radiation treatment (hypofractionation) for cervical cancer works as well as the standard longer course. Cervical cancer is one of the most common cancers in women in India, and many patients have trouble completing treatment because it takes several weeks and requires many hospital visits. In this trial, females with locally advanced cervical cancer will be randomly assigned to one of two treatment groups. One group will receive the standard radiation schedule with External Beam RadioTherapy (EBRT) over about 5 weeks, weekly cisplatin chemotherapy, and brachytherapy. The other group will receive a shorter, hypofractionated external beam radiotherapy schedule over about 3 weeks, the same chemotherapy, and brachytherapy. Researchers will compare the two groups to see whether the hypofractionated schedule is non-inferior to the standard radiation therapy schedule. The main outcomes will be tumor control in the pelvis, side effects, survival, and quality of life. If the hypofractionated schedule meets the non-inferiority limit, it could reduce treatment time, improve patient convenience, and help more people receive treatment in busy cancer centers in emerging countries.
Trial Details
NCT Number NCT07625943
Lead Sponsor All India Institute of Medical Sciences
Collaborators: Varian, a Siemens Healthineers Company
Conditions
(from sponsor)		 Cervical Cancer Squamous Cell, Cervical Cancer
Related terms Uterine Cervical Neoplasms
Enrollment 396 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov