Non-small cell lung cancer (NSCLC) Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Pre-study evaluation:
The following baseline assessments need to be performed within the 42 days prior to the radiotherapy planning scan:
1. History (including severity
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Queries about inclusion criteria should be addressed prior to entry into the study. Patients are eligible for the study if all of the following criteria are met: 1. Histologically or cytologically confirmed stage III NSCLC 2. World Health Organization (WHO) performance status 0 or 1 3. Life expectancy greater than 6 months 4. Inoperable disease as assessed by a Lung Cancer Multi-Disciplinary Team (MDT) with input from Thoracic Surgeon; or operable but the patient refuses surgery 5. Aged 18 or over (no upper age limit), either sex 6. No prior thoracic radiotherapy 7. No prior lobectomy/pneumonectomy 8. No prior systemic chemotherapy 9. Willing and able to give informed consent 10. Adequate pulmonary function test (PFT) results: forced expiratory volume in one second (FEV1) and/or carbon monoxide transfer factor (DCLO) greater than or equal to 40% of predicted 11. For women with childbearing potential: 11.1. Negative pregnancy test 11.2. Adequate contraceptive precautions
Exclusion criteria
Exclusion criteria: Patients are ineligible for the trial if any of the following criteria are met: 1. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons 2. Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, cardiovascular disease such as congestive cardiac failure) 3. Previous diagnosis of interstitial lung disease 4. Previous diagnosis of spinal cord disease 5. Women of childbearing potential who are not practicing adequate contraceptive precautions 6. Women who are pregnant or lactating 7. Connective tissue disorders (e.g. scleroderma, systemic lupus erythematosus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of dose escalation achievable. This will be determined by the incidence and grade of potential dose limiting toxicities: 1. Pulmonary toxicity: 1.1. Early radiation pneumonitis (ERTP): occurring within 6 months of finishing RT 1.2. Late radiation pneumonitis (LRTP)/fibrosis: occurring after the six months period following RT 1.3. Changes in pulmonary function tests (PFTs) 2. Oesophageal toxicity: 2.1. Acute oesophagitis: occurring during RT or up to three months post RT 2.2. Chronic oesophagitis/stricture: occurring/persisting beyond three months post-completion of RT 3. Spinal cord toxicity 4. Cardiac toxicity Toxicity will be assessed at the following post-treatment assessments: 1. Weekly until 1 month post-treatment 2. Monthly until 6 months post-treatment 3. Three-monthly until 2 years post-treatment 4. Six-monthly until 3 years post-treatment 5. Annually until 5 years post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tumour response 2. Two year survival 3. Overall survival 4. Progression free survival 5. Local control Follow-up visits measuring weight (performance status) and adverse events (dyspnoea score) will occur at the following timepoints: 1. Weekly until 1 month post-treatment 2. Monthly until 6 months post-treatment 3. Three-monthly until 2 years post-treatment 4. Six-monthly until 3 years post-treatment 5. Annually until 5 years post-treatment In addition, the following investigations will be requested: 1. CXR: at months 1, 2, 5, 12, 18, 24 post-treatment 2. CT chest/abdomen: at months 3 and 6 post-treatment 3. PFTs: at months 3, 6 and 12 post-treatment 4. ECG: at months 6 and 12 post-treatment Appropriate investigations and assessments will be performed if the patient becomes symptomatic in between trial follow-up appointments. | — |
Countries
England, United Kingdom
Outcome results
None listed