ADSCaN: A Randomised Phase II trial of Accelerated, Dose escalated, Sequential Chemo-radiotherapy in Non small cell lung cancer
Stage III Non-Small Cell Lung Cancer
Minimisation incorporating a random factor will be used to allocate patients between treatment arms A:B:C:D:E so that an overall study ratio of 2:1:1:1:1 is achieved. Patients will only be randomised between the arms currently available at their hospital. Arm A (Standard Arm): Patients will receive one radiotherapy session per day for 4 weeks (55Gy in 20 fractions over 26-28 days) Arm B CHART-ED: Patients will receive 3 radiotherapy sessions per day for 2½ weeks (54Gy, 36 fractions, 12 days then 10.8Gy, 6 fractions (day 15-17)). Arm C: IDEAL: Patients will receive one radiotherapy session per day for 5 weeks (Isotoxic radiotherapy 30 fractions, 5 weeks, prescribed dose 63-71Gy). Arm D: I-START: Patients will receive one radiotherapy session per day for 4 weeks (Isotoxic radiotherapy 20 fractions, 4 weeks total dose of 55 – 65 Gy). Arm E: Isotoxic IMRT: Patients will receive 2 sessions per day for 4 weeks (Isotoxic regime IMRT, individualised dose escalation to a maximum 79.2Gy in 1.8Gy over 4 weeks BD). For all trial arms, once patients have completed treatment they will enter follow up and should be reviewed at months - 2, 3, 4, 6, 9, 12, 15, 18, 24 and 36 from randomisation. Thereafter annual visits should be performed until the end of the study period (June 2021). Follow up visits at more frequent intervals should be undertaken at the discretion of the participating Investigator.
1. Histologically or cytologically confirmed stage III NSCLC 2. Performance status (PS) – ECOG 0-2 Patients with PS 2 can only be included if the local investigator deems the general condition is explained by disease or the primary chemotherapy treatment 3. Inoperable disease, unsuitable for concurrent chemo-radiotherapy, in the opinion of the treating Oncologist 4. Patients who have had a complete response, partial response or stable disease on CT assessment after 2 cycles of platinum based chemotherapy 5. Willing and able to give written informed consent 6. Aged 16 or over 7. Adequate PFT results: FEV1 and/or KCO ≥ 40% of predicted
1. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons 2. Medically unstable (unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, ischaemic heart disease) 3. Connective tissue disorders (Scleroderma, Systemic Lupus Erythematosus) 4. Clinically significant interstitial lung disease 5. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol 6. Pregnant or lactating women 7. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule