PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 375
- 试验地点
- 120
- 主要终点
- Incidence of chest wall tract metastasis 6 months from randomisation
研究概览
简要总结
The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.
详细描述
Mesothelioma is a rare form of cancer affecting the protective lining that covers many of the body's internal organs. The most commonly affected areas are the lungs and internal chest wall. In the UK over 2300 patients are diagnosed with mesothelioma each year and the numbers are increasing.
As part of the diagnosis and treatment of mesothelioma, patients may undergo a procedure which involves inserting a thin tube into the chest wall enabling an internal examination and for any biopsies or samples of fluid to be taken. These procedures can result in the development of skin lumps or nodules along the tract created by inserting the tube. To try and reduce the risk of these nodules developing in the tract or at the site of the scar, radiotherapy can be given to the chest wall at the site of the tract after the procedure has been performed; this type of radiotherapy is known as prophylactic irradiation of tracts or PIT.
Although many hospitals already give patients this type of radiotherapy treatment to the chest wall we still do not know if the treatment works. This trial has been designed to answer the question about the effectiveness of PIT radiotherapy. If PIT is found to be effective in preventing or delaying the development of these skin nodules then it can be offered to all patients as part of their treatment. However, if we discover that PIT is not effective this will save patients from undergoing ineffective treatment and having to spend time making unnecessary extra visits to hospital
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either sex, age ≥ 18 years
- •Diagnosis of mesothelioma by multi-disciplinary team (MDT). All histological subtypes are eligible for the trial
- •ECOG performance status 0-2 (Appendix C)
- •Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT
- •Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy (mini-thoracotomy), local anaesthetic thoracoscopy or chest drain
- •Able to start radiotherapy within 42 days (6 weeks) of the most recent chest wall procedure
- •Chest wall intervention scar visible at time of randomisation
- •Radiotherapy target volume acceptable by the local radiotherapist
- •Patients enrolled on other clinical trials could be considered after discussion with the chief investigators
排除标准
- •Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)
- •Previous radiotherapy to the region of the chest wall intervention site
- •Indwelling pleural catheter in-situ at the intervention site
- •Patients currently receiving chemotherapy
研究组 & 干预措施
PIT Arm
干预措施: Prophylactic Irradiation of Tracts (PIT) (Radiation)
No PIT Arm
结局指标
主要结局
Incidence of chest wall tract metastasis 6 months from randomisation
时间窗: 6 months
次要结局
- Time from randomisation to chest wall tract metastasis(Weeks)
- Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)(Weeks)
- Acute and late skin radiotherapy toxicity(Weeks)
- Pain from chest wall tract metastasis(Weeks)
研究者
Brynn Chappell
Clinical Trials Project Manager
The Christie NHS Foundation Trust