RecruitingNot ApplicableNCT03997110

Palliative Radiation for Advanced Cervical Cancer

Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III Randomized Trial

Sponsor

Tata Memorial Hospital

Enrollment

230 participants

Start Date

Jun 19, 2020

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a shorter, gentler course of radiation therapy for women with advanced cervical cancer who cannot receive the standard full course of curative radiation — often because their cancer is too large, has spread to nearby structures, or their kidneys are not working well enough for standard treatment. **You may be eligible if...** - You have locally advanced cervical cancer (Stage IIIB-IVA) that cannot be treated with curative intent radiation or surgery - Your cancer has formed a large connection (fistula) to the bladder or rectum making curative treatment not possible - You have poor kidney function preventing standard chemoradiation - You are not a candidate for surgery to remove pelvic organs (pelvic exenteration) **You may NOT be eligible if...** - You are able to receive full-course curative radiation or chemoradiation - Your cancer is at an earlier, more treatable stage - You are already receiving another cancer treatment 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

RADIATIONShort 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.

RADIATIONLong 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