Back to resultsPhase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy (PLANET)
Primary Purpose
Non Small Cell Lung Cancer, Locally Advanced Disease
Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Standard radiochemotherapy to 68 Gy
Dose escalated radiochemotherapy up to 84 Gy
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Radiotherapy, Dose escalation, Normal tissue constraints, Locally advanced disease, Good performance status
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.
- 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.
Sites / Locations
- Department of Oncology, Norrlands Universitetssjukhus
- Department of Oncology, Karolinska University Hospital
- Department of Oncology, Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A:Standard radiochemotherapy
Arm B Escalated radiochemotherapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Numbers of patients without progression of locoregional disease
Measured with CT-scan according to the RECIST criteria for response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01664663
Brief Title
Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy
Acronym
PLANET
Official Title
Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Safety analysis showed increased grade 5 toxicity in experimental arm.
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ass. Prof. Jan Nyman
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Locally Advanced Disease
Keywords
Radiotherapy, Dose escalation, Normal tissue constraints, Locally advanced disease, Good performance status
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A:Standard radiochemotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm B Escalated radiochemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Standard radiochemotherapy to 68 Gy
Intervention Type
Radiation
Intervention Name(s)
Dose escalated radiochemotherapy up to 84 Gy
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
36 monts after randomization
Secondary Outcome Measure Information:
Title
Numbers of patients without progression of locoregional disease
Description
Measured with CT-scan according to the RECIST criteria for response
Time Frame
36 months after randomization
Other Pre-specified Outcome Measures:
Title
Overall survival
Time Frame
36 months after randomization
Title
Numbers of patients with adverse events
Description
According to CTC version 4.0
Time Frame
Up to 36 months after randomization
Title
Quality of life
Description
Measured by questionaires, EORTC QLQ 30 + LC 14
Time Frame
Up to 36 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Nyman, Ass. prof
Organizational Affiliation
Swedish Lung Cancer Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Norrlands Universitetssjukhus
City
Umeå
State/Province
Norrland
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Department of Oncology, Karolinska University Hospital
City
Stockholm
State/Province
Stockholm county
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Department of Oncology, Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
30032828
Citation
Hallqvist A, Bergstrom S, Bjorkestrand H, Svard AM, Ekman S, Lundin E, Holmberg E, Johansson M, Friesland S, Nyman J. Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC appears excessively toxic: Results from a prematurely terminated randomized phase II trial. Lung Cancer. 2018 Aug;122:180-186. doi: 10.1016/j.lungcan.2018.06.020. Epub 2018 Jun 18.
Results Reference
derived
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Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy
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