RANDOMISED CONTROLLED TRIAL ANALYSING DOSIMETRY AND NEUROCOGNITIVE OUTCOMES OF HIPPOCAMPAL SPARING RADIOTHERAPY IN HEAD AND NECK CANCERS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Dosimetric differences between hippocampal sparing & non-hippocampal sparing radiotherapy in patients of head & neck cancers
研究概览
简要总结
Head and Neck cancers are one of the most common cancers in many developing countries like India. The mainstay of treatment for loco-regionally advanced head and neck cancer is either surgery followed by adjuvant radiation therapy or definitive radiotherapy with/ without concurrent chemotherapy. In radiotherapy in head and neck malignancies, the hippocampus has not been conventionally considered as a organ-at risk and has not been delineated and spared.
In radiotherapy to the brain in case of CNS malignancies, recent evidence has demonstrated the effectiveness of hippocampal sparing in reducing radiation-related cognitive decline and QoL, using more conformal techniques like Intensity Modulated Radiotherapy [IMRT], Volumetric Modulated Arc Therapy [VMAT], and Proton Therapy. Recent dosimetric studies have established that the hippocampus dose in routine head and neck radiotherapy is often significant and may potentially lead to hippocampal toxicities.
This trial aims to firstly dosimetrically study the hippocampal radiation dose with and without specific hippocampal avoidance techniques in radiotherapy planning without compromising on the target structure doses. Secondly, this trial aims to study whether hippocampal sparing in radiotherapy leads to measurable reduction in neurocognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Head and neck Squamous or Adeno carcinoma post-operative with PTV involving high masticator space or high infratemporal fossa or nasal cavity or paranasal sinuses planned for adjuvant radiotherapy with or without concurrent chemotherapy with equivalent prescription doses in the range of 60-66 Gy (depending on margin status).
- •Cancers of the nasopharynx or nasal cavity or paranasal sinuses or orbit planned for definitive radiotherapy with or without concurrent chemotherapy with equivalent prescription doses above 66-70Gy.
- •Age: 18-75years.
- •Non-Metastatic disease.
- •Curative Intent of treatment.
排除标准
- •Prior Radiotherapy to Head and Neck region/ Brain.
- •Gross tumor volume in the hippocampal region or within a 5mm margin around the hippocampus.
- •Previous or present history of neurological diseases or syndromes.
- •Pregnant or Lactating women.
- •Contraindications to MR imaging such as Implanted Metal devices or foreign bodies, severe claustrophobia.
- •Co-existing surgical or medical conditions precluding the use of Radical/Adjuvant RT/CTRT.
结局指标
主要结局
Dosimetric differences between hippocampal sparing & non-hippocampal sparing radiotherapy in patients of head & neck cancers
时间窗: Radiotherapy Planning before Radiotherapy Treatment
次要结局
- Neurocognitive function measured by ADDENBROOKE’S COGNITIVE EXAMINATION – ACE-III(3- & 6-months post radiotherapy follow-up)
- Acute toxicities as per RTOG criteria will be recorded(During Radiotherapy & 1 & 3 months post radiotherapy treatment)