Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.

Detailed Description
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This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

Official Title
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Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Conditions
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Non Small Cell Lung Cancer, Locally Advanced Disease

Intervention / Treatment
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* Radiation: Standard radiochemotherapy to 68 Gy
* Radiation: Dose escalated radiochemotherapy up to 84 Gy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological diagnosis of NSCLC stage IIIA-B. Nonresectable or medically inoperable patients. No prior chemo- or radiotherapy for NSCLC. PS 0-1. FEV1 > 1 l or > 40% and CO diffusion capacity > 40%. Patient compliance and geographic proximity that allow adequate follow-up. Adequate bone marrow reserve: WBCC >3.0, platelets >100, haemoglobin > 100. Written informed concent. Effective use of contraception. Exclusion Criteria: Excessive weight loss within 6 months (> 10%). Supraclavicular nodes. Apical tumors-pancoast. T4 tumors with separate manifestations in different lobes. Evidence of active serious infections. Inadequate liver function. Inadequate kidney function. Pregnancy. Breast feeding. Serious concomitant systemic disorder. Second primary malignancy the last 5 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A:Standard radiochemotherapy<br>Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation. | Radiation: Standard radiochemotherapy to 68 Gy<br> <br> |
| Experimental: Arm B Escalated radiochemotherapy<br>Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation. | Radiation: Dose escalated radiochemotherapy up to 84 Gy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 36 monts after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of patients without progression of locoregional disease | Measured with CT-scan according to the RECIST criteria for response | 36 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Dose escalation, Normal tissue constraints, Locally advanced disease, Good performance status