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

This study is currently recruiting participants.
Verified August 2012 by Swedish Lung Cancer Study Group
Sponsor:
Information provided by (Responsible Party):
Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01664663
First received: August 10, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
 Radiation: Standard radiochemotherapy to 68 Gy
Radiation: Dose escalated radiochemotherapy up to 84 Gy
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Swedish Lung Cancer Study Group:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 36 monts after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 126
Study Start Date: September 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664663

Contacts
Contact: Jan Nyman, Ass Prof 0046313427927 jan.nyman@oncology.gu.se
Contact: Andreas Hallqvist, MD PhD 0046739845114 andreas.hallqvist@oncology.gu.se

Locations
Sweden
Department of Oncology, Norrlands Universitetssjukhus Recruiting
Umeå, Norrland, Sweden, 901 85
Contact: Mikael Johansson, MD PhD     0046703711414     mikael.johansson@onkologi.umu.se    
Principal Investigator: Per Bergström, MD            
Sub-Investigator: Mikael Johansson, MD PhD            
Department of Oncology, Karolinska University Hospital Recruiting
Stockholm, Stockholm county, Sweden, 171 76
Contact: Signe Friesland, MD PhD         signe.friesland@karolinska.se    
Principal Investigator: Signe Friesland, MD PhD            
Sub-Investigator: Hedvig Björkestrand, MD            
Sub-Investigator: Gunnar Wagenius, MD PhD            
Sub-Investigator: Johan Falkenius, MD            
Sub-Investigator: Rolf Lewensohn, Prof            
Department of Oncology, Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götaland, Sweden, 413 45
Contact: Jan Nyman, Ass prof     0046313427927     jan.nyman@oncology.gu.se    
Principal Investigator: Stefan Bergström, MD PhD            
Principal Investigator: Michael Bergqvist, Ass Prof            
Sub-Investigator: Kristina Nilsson, MD PhD            
Sub-Investigator: Andreas Hallqvist, MD PhD            
Principal Investigator: Jan Rzepecki, MD            
Sub-Investigator: Hillevi Rylander, MD            
Sub-Investigator: Hedda Haugen, MD PhD            
Sub-Investigator: Edvard Abel, MD            
Principal Investigator: Erik Lundin, MD            
Principal Investigator: Martin Rydin, MD            
Principal Investigator: Mihalj Seke, MD            
Principal Investigator: Jan Nyman, Ass prof            
Sponsors and Collaborators
Ass. Prof. Jan Nyman
Investigators
Principal Investigator: Jan Nyman, Ass. prof Swedish Lung Cancer Study Group
  More Information

No publications provided

Responsible Party: Ass. Prof. Jan Nyman, Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden, Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier: NCT01664663     History of Changes
Other Study ID Numbers: PLANET
Study First Received: August 10, 2012
Last Updated: August 16, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Swedish Lung Cancer Study Group:
Radiotherapy
Dose escalation
Normal tissue constraints
Locally advanced disease
Good performance status

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013