Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
18 Years
80 Years
Both
Non Small Cell Lung Cancer
Trial Information
Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
36 monts after randomization
Safety Issue:
No
Principal Investigator
Jan Nyman, Ass. prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Swedish Lung Cancer Study Group
Authority:
Sweden: Medical Products Agency
Study ID:
PLANET
NCT ID:
NCT01664663
Start Date:
September 2011
Completion Date:
October 2017
Related Keywords:
- Non Small Cell Lung Cancer
- Radiotherapy
- Dose escalation
- Normal tissue constraints
- Locally advanced disease
- Good performance status
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
