Palliative Radiation for Advanced Cervical Cancer

NCT03997110 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Hospital

Phase

N/A

Started

2020-06-19

Last updated

2026-02-17

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Short course palliative radiation.Long course palliative treatment.

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

Study 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

FEMALE

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Locally advanced cervical cancer (Stage IIIB-IVA) deemed unsuitable for full course radical pelvic radiotherapy or chemoradiation due to the following reasons: * Very large volume hard fixed disease infiltrating pelvic wall muscles and ligaments on clinical examination also classified clinically as "frozen pelvis" wherein curative intent treatment is not envisaged or feasible. * Fistulous communication between tumour growth and rectum and bladder \>2x2 cm in size (as judged by cystoscopy for bladder infiltration or clinical or proctosigmoidoscopy examination for rectal/sigmoid infiltration) wherein radical intent treatment is not intended or feasible and patient is not a candidate for pelvic exenteration. * Deranged renal parameters as measured by Serum Creatinine \>3 mg/dl wherein diversion nephrostomy is not planned by the multidisciplinary team due to anticipated poor clinical outcomes.Furthermore concurrence for palliative intent radiotherapy should be corroborated by 2 staff radiation oncologists. 2. Moderate to Severe Pain on Numerical Rating Score (Score 4 or higher). 3. Anticipated survival \< 12 months. 4. Patients with stage IVB with local disease extent as described in section 1 but systemic chemotherapy is not possible either due to deranged renal function or anticipated poor tolerance. Exclusion Criteria: 1. Patients with distant metastasis needing upfront systemic therapy. 2. Presence of retroviral disease 3. Non-compliant for follow up. 4. Expected survival \<3 months.

Primary outcome measure(s)

Pain Relief (Numerical pain rating scale will be used) — 1 week, 4 week, 7 week, 12 weeks
Pain relief in the experimental arm as compared to the control arm from treatment until 12 weeks from start of radiotherapy will be assessed. Pain relief will be assessed at 12 weeks from start of radiotherapy. (Pain has been chosen as the primary endpoint as it is the primary complaint in almost 2/3 rd of patients. Numerical pain rating scale has been chosen for objective pain assessment as it is easy to use and has been proven to be a reliable tool in multiple studies. Pain score will be documented on 11-scale numerical pain rating scale (NRS) and qualified into one of the following categories: i)Pain score of 0-3- No to mild pain ii)Pain score 4-7- Moderate pain iii)Pain score \>7- Severe pain

Trial sites (1)

Facility	City	Region	Status
Tata Memorial Hospital	Mumbai	Maharashtra	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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