Concurrent Chemo-radiation Form NSCLC to a Individualized MLD

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT00572325
• Lead Sponsor: Maastricht Radiation Oncology

Brief Summary

Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy

Detailed Description

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):

* MLD=19 Gy when Fev1 and DLCO\>50% of the predicted value

* MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value

* MLD=10 Gy when Fev1 and/or DLCO \<40% of the predicted value

Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:54 Gy. Maximal tumor dose:69 Gy

Radiotherapy will be delivered as follows:

1. First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions

2. Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Chemotherapy schedules allowed:

1. 1-2 cycles induction chemotherapy; any type will be registered.

2. concurrent part:(day1= first day of radiotherapy)

1. cisplatin - vinorelbine

* Cisplatin 50 mg/m2 day 2 and day 9

* Vinorelbine 20 mg/m2 day 2 and day 9

* Cisplatin 40mg/m2 day 23

* Vinorelbine 15mg/m2 day 23 and day 30

2. cisplatin - docetaxel

* Cisplatin 50 mg/m2 day 2,9 and 29

* Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29

3. cisplatin - etoposide

* Cisplatin 60 mg/m2 day 1

* Docetaxel 120 mg/m2 day 1-3

Q 3 weeks, 3 cycles

When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Study Completion: 2009-05
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-20
• Last Update Posted: 2010-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Histological or cytological proven NSCLC
• UICC stage I-III
• Performance status 0-2
• FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria

• Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
• UICC stage IV
• Performance status 3 or more
• FeV 1 and DLCO < 30% of the age-predicted value

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death	2,3 and 5 years

Secondary Outcome Measures

Name	Time	Method
-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence	2,3 and 5 years

Trial Locations

Locations (1)

MAASTRO clinic, Maastricht Radiation Oncology; 🇳🇱 Maastricht, Netherlands