Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy (PLANET)
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.
Non Small Cell Lung Cancer
Radiation: Standard radiochemotherapy to 68 Gy
Radiation: Dose escalated radiochemotherapy up to 84 Gy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy|
- Progression free survival [ Time Frame: 36 monts after randomization ] [ Designated as safety issue: No ]
- Numbers of patients without progression of locoregional disease [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]Measured with CT-scan according to the RECIST criteria for response
- Overall survival [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
- Numbers of patients with adverse events [ Time Frame: Up to 36 months after randomization ] [ Designated as safety issue: Yes ]According to CTC version 4.0
- Quality of life [ Time Frame: Up to 36 months after randomization ] [ Designated as safety issue: No ]Measured by questionaires, EORTC QLQ 30 + LC 14
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||October 2015|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A:Standard radiochemotherapy
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|
Experimental: Arm B Escalated radiochemotherapy
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|
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.
|Department of Oncology, Norrlands Universitetssjukhus|
|Umeå, Norrland, Sweden, 901 85|
|Department of Oncology, Karolinska University Hospital|
|Stockholm, Stockholm county, Sweden, 171 76|
|Department of Oncology, Sahlgrenska University Hospital|
|Gothenburg, Västra Götaland, Sweden, 413 45|
|Principal Investigator:||Jan Nyman, Ass. prof||Swedish Lung Cancer Study Group|