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临床试验/CTRI/2025/03/082834
CTRI/2025/03/082834尚未招募3 期

Dysphagia-Optimised Intensity Modulated Radiation Therapy vs Standard Intensity Modulated Radiation Therapy in post-operative cases of oral cavity carcinoma

Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Acute Toxicity

研究概览

简要总结

Surgery is the mainstay of treatment for resectable oral cavity cancer. However, patients with poor prognostic factors are also offered adjuvant RT with or without CT. With combined modality treatment, patients have to suffer from dysphagia especially because of irradiation of dysphagia aspiration related structures(DARS) during RT. With modern RT techniques like IMRT, doses to DARS and thus subsequently swallowing dysfunction could be minimized. Patients of both gender of the age group 18-70 years will be included. Patients with prior Chemotherapy and/or Radiotherapy or synchronous malignancy will be excluded. The present study is a randomized controlled study and the study aims to compare two different IMRT techniques i.e., dysphagia optimised IMRT (DO-IMRT) v/s standard IMRT (S-IMRT) in patients of oral cavity cancer who will be receiving adjuvant RT with or without Concurrent CTH. The primary end point is acute toxicity and the secondary end points are loco-regional control, disease-free survival, quality of life, late toxicty and overall survival.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Histologically proven post-operative oral cavity carcinoma.
  • Squamous-cell carcinoma histology.
  • Age 18-70 years of either sex.
  • pT1-pT4, N0-3,M
  • ECOG of 0-
  • Adequate hematologic, renal and hepatic function.

排除标准

  • Pre-existing swallowing dysfunction.
  • Any synchronous or metachronous malignancy.
  • Patients receiving neo-adjuvant chemotherapy.
  • Prior chemotherapy and /or radiotherapy to head and neck region.

结局指标

主要结局

Acute Toxicity

时间窗: 3 months

次要结局

  • Late toxicity.(Disease free survival)

研究者

发起方
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Lahunshisha Kharbuli

Sir Sunderlal Hospital,Institute of Medical Sciences, BHU.

研究点 (1)

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