The PREVENT study: Does PRE-habilitation improVe pErformance status in uN-resectable stage III NSCLC patients undergoing chemo-radioTherapy? - A pilot study

Ballarat Health Services (Base Hospital) - Ballarat Central0 个研究点目标入组 20 人开始时间: 2021年11月24日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•1. Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8.
•2. No evidence of metastatic disease by whole body PET/CT scan, diagnostic quality CT scan, and brain imaging
•3. Have un-resectable disease, that is amenable to be treated with radical-intent chemo-radiotherapy, as decided through a thoracic multidisciplinary meeting.
•4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•5. Have adequate pulmonary function test (PFT) as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and the carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value.
•6. Fulfill the guideline requirements in the APSS.
•7. Have capacity to provide written informed consent for the trial.

•1. A women of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to treatment allocation.
•2. Has small cell lung cancer. Mixed tumours will be categorized by the predominant cell type: if small cell elements are present, the participant is ineligible.
•3. Has had documented weight loss >10% in the preceding 3 months.
•4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

发起方

Ballarat Health Services (Base Hospital) - Ballarat Central