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

Phase 2TerminatedNCT01664663

Ass. Prof. Jan Nyman37 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer Locally Advanced Disease

Interventions

Standard radiochemotherapy to 68 GyRADIATION

Dose escalated radiochemotherapy up to 84 GyRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Department of Oncology, Norrlands Universitetssjukhus

Umeå, Norrland, Sweden

Department of Oncology, Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Outcomes

Primary Outcomes

Progression free survival

Time frame: 36 monts after randomization

Secondary Outcomes

Numbers of patients without progression of locoregional disease

Measured with CT-scan according to the RECIST criteria for response

Time frame: 36 months after randomization

Data from ClinicalTrials.gov

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