Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III randomized trial (RAPPAL Study) - RAPPA

Tata memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Locally advanced cervical cancer (Stage III B-IV A) 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 â??frozen pelvisâ?? 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 exentration.
•- 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.

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