Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Ass. Prof. Jan Nyman
- Enrollment
- 37
- Locations
- 3
- Primary Endpoint
- Progression free survival
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Ass. Prof. Jan Nyman
Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden
Swedish Lung Cancer Study Group
Eligibility Criteria
Inclusion Criteria
- •Histological or cytological diagnosis of NSCLC stage IIIA-B.
- •Nonresectable or medically inoperable patients.
- •No prior chemo- or radiotherapy for NSCLC.
- •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 \>
- •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.
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 36 monts after randomization
Secondary Outcomes
- Numbers of patients without progression of locoregional disease(36 months after randomization)