Clinical Research Directory
Browse clinical research sites, groups, and studies.
Palliative Radiation for Advanced Cervical Cancer
Sponsor: Tata Memorial Hospital
Summary
The present study is proposed to compare a rapid fractionation schedule of 1 week compared to a protracted schedule of 6-8 weeks for palliation for locally advanced cervical cancer.
Official title: Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III Randomized Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2020-06-19
Completion Date
2026-08-01
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Short course palliative radiation.
Week 1: Patients in the experimental arm will be treated with short course radiotherapy (25Gy/5#). The dose fractionation of 25 Gy in 5# over a week will be used. Week 4: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#. The patients who will be found unsuitable for brachytherapy will be kept under observation. Week 12: After treatment completion, response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes/no • Vaginal discharge- yes/ no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity. Follow up: Patients follow up will be utilizing standard of care imaging and lab investigations used for the patients. Patients will be evaluated every 3 months for the study duration.
Long course palliative treatment.
Week1: All the patients will receive external sitting of radiation treatment, first fraction of 10 Gy. Week4: All the patients will receive external sitting of radiation treatment, second fraction of 10 Gy. Week7: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#.The patients who will be found unsuitable for brachytherapy will receive another sitting of external radiation, third fraction of 10 Gy. Week 12: After treatment completion response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes/ no • Vaginal discharge- yes/no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity
Locations (1)
Tata Memorial Hospital
Mumbai, Maharashtra, India