A phase III randomised trial of sequential chemotherapy followed by radical radiotherapy versus concurrent chemo-radiotherapy followed by chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) and good performance status.

Completed

• Conditions: on Small Cell Lung Cancer (NSCLC); Cancer; Lung cancer

• Registration Number: ISRCTN13746987
• Lead Sponsor: Sponsor not defined - Record provided by CRUK and UCL CTC (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25304298

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-03-10
• Study Completion: 2009-04-30
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

1. Histologically or cytologically confirmed stage III Non-Small Cell Lung Cancer (NSCLC)
2. Performance status - Eastern Cooperative Oncology Group (ECOG) zero or one
3. Life expectancy greater than three months
4. Tumour judged as inoperable by thoracic surgeon or after review by MultiDisciplinary Team (MDT) including thoracic surgeon, using British Thoracic Society guidelines
5. Age 18 or over
6. No prior chemotherapy, radiotherapy or investigational agents
7. Willing and able to give informed consent
8. Willing and able to complete quality of life forms
9. Patient considered able to tolerate platinum based chemotherapy and radical radiotherapy

Exclusion Criteria

1. Stage IIIB disease with pleural effusion cytologically proven to be malignant
2. Superior vena cava obstruction
3. Other previous or current malignant disease likely to interfere with protocol treatment or comparisons
4. Abnormal Liver Function Tests (LFTs) with any of: Alkaline Phosphatase, Gamma Glutamyl Transferase, Transaminases or Bilirubin more than 1.5 times Upper Limit of Normal range (ULN)
5. Hypercalcaemia
6. Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications
7. Pregnancy and lactation. Effective contraception is mandatory for all patients (of reproductive potential) if sexually active
8. Active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy.

Secondary Outcome Measures

Name	Time	Method
1. Compare the progression-free survival of patients treated with these regimens. <br>2. Compare the local progression-free survival (local control). <br>3. Compare the hematological, pulmonary, esophageal, and neurological toxicities. <br>4. Compare the response. <br>5. Compare the quality of life. <br>6. Compare the cost-effectiveness.