A randomised phase III study comparing induction chemotherapy to daily low dose Cisplatin both combined with high dose radiotherapy in patients with inoperable non-small cell lung cancer stage I, II and III

Completed

• Conditions: ung cancer; Malignant neoplasm of bronchus or lung; Cancer

• Registration Number: ISRCTN73271276
• Lead Sponsor: etherlands Cancer Institute, Antoni van Leeuwenhoek Hospital (NKI/AVL) and Academic Medical Centre (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Pathologically confirmed non-small cell lung cancer (NSCLC)
2. Medically inoperable or irresectable NSCLC T 1-4, N0-3, M0
3. Age >18 years
4. Weight loss <10% in the last 3 months
5. FeV1 >0.99l, TLCO >59%

Exclusion Criteria

1. Previous chemotherapy and/or radiotherapy of the chest
2. Superior Vena cava syndrome
3. Hemoptysis causing a decrease of the blood haemoglobin of >1 mmol/l within 24 hours
4. Pleural or pericardial effusion (except if negative cytology)
5. Uncontrolled infection
6. Maximal length of the esophagus receiving 40 Gy of more than 18 cm, or maximal length of the esophagus receiving 66 Gy of more than 12 cm
7. Serious medical risk factors involving any of the major organ systems which may prevent adherence to the treatment schedule
8. Patients with pre-existant fibrotic lung disease
9. Creatinine clearance <70 ml/min or creatinine >1.25 x normal value
10. Bone marrow hypoplasia (Hb 6.8 mmol/l, WBC 4 x 10^9/l, platelets 100 x 10^9/l)
11. Recent myocardial infarction(<6 months) or evidence of heart failure
12. Impossibility to limit the spinal cord dose to a maximum of 50 Gy
13. Impossibility to exclude 2/3 of the heart from the boost volume

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Disease-free survival<br>2. Local control<br>3. Pattern of recurrence.

Secondary Outcome Measures

Name	Time	Method
1. Acute and late toxicity<br>2. Quality of Life.