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临床试验/CTRI/2023/10/058621
CTRI/2023/10/058621尚未招募2 期

Accelerated Hypofractionated Palliative Radiotherapy Vs Standard Hypofractionated Palliative Radiotherapy With Concurrent Chemotherapy In Locally Advanced Head And Neck Carcinoma: A Randomised Controlled Study

AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Tumour Response Rate

研究概览

简要总结

In patients with locally advanced head and neck carcinoma, Palliativeradiotherapy, in general, has the potential to greatly improve the quality oflife (QoL) of these patients and may actually increase overall survival. Considerationsfor an optimal palliative radiotherapy schedule are: significant tumourregression and symptom control within a short overall treatment time (OTT) withminimal side effects. Frequently some form of hypofractionation is opted for.The benefit of an increased tumour cell kill because of the large fraction sizein a short OTT is counteracted, from radiobiological point of view, by anincreased potential for late side effects. However, late radiation toxicity isoften less relevant in patients treated in palliative setting. Accelerated fractionationis another option. The rationale for accelerated fractionation is thatreduction in overall treatment time decreases the opportunity for tumour cellregeneration, thereby increasing the probability of tumour control for a giventotal dose. Because overall treatment time has little influence on theprobability of late normal tissue injury, a therapeutic gain should berealized, provided the interval between dose fractions is sufficient forcomplete repair to take place. Thepresent study has been designed to address the benefit of accelerated moderately-hypofractionatedpalliative radiotherapy with concurrent chemotherapy over standard hypofractionatedpalliative radiotherapy with concurrent chemotherapy on the background ofprevious study from this centre.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Not Applicable

入排标准

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

入选标准

  • Treatment naive, Histo-pathologically proven Squamous Cell Carcinoma of head and neck region excluding nasopharyngeal, para-nasal sinus and salivary gland primary -Defined as incurable or palliative intent by Head and Neck multidisciplinary team (MDT) -Adequate organ functions and bone marrow reserve -Eastern Co-operative Oncology Group Performance Score (ECOG PS)- (0-3) -Age: 18- 70 years -Negative viral serology markers (HIV, HBsAg, HCV) -Giving written Informed consent.

排除标准

  • Nasopharyngeal, para-nasal sinus or salivary gland primary -Recurrent disease -Metastatic disease -Patients who have previously received oncologic treatment with surgery, radiotherapy or chemotherapy -Pregnant patients -Synchronous malignancy or any other malignancy with in last 5 years -Known uncontrolled medical comorbidities which could impact QOL.

结局指标

主要结局

Tumour Response Rate

时间窗: Tumor Response- 3 weeks, 3 months, 6 months after palliative radiotherapy completion. | Quality of Life- baseline, 3 months, 6 months after palliative radiotherapy completion.

Quality of Life

时间窗: Tumor Response- 3 weeks, 3 months, 6 months after palliative radiotherapy completion. | Quality of Life- baseline, 3 months, 6 months after palliative radiotherapy completion.

次要结局

  • Assessment of Acute Toxicities(3 months)
  • Progression Free Survival(6 months)
  • Overall Survival(6 months)

研究者

发起方
AIIMS, New Delhi
申办方类型
Government medical college

研究点 (1)

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