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

This study has been terminated.
(Safety analysis showed increased grade 5 toxicity in experimental arm.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664663
First Posted: August 14, 2012
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
  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 Locally Advanced Disease Radiation: Standard radiochemotherapy to 68 Gy Radiation: Dose escalated radiochemotherapy up to 84 Gy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 36 monts after randomization ]

Secondary Outcome Measures:
  • Numbers of patients without progression of locoregional disease [ Time Frame: 36 months after randomization ]
    Measured with CT-scan according to the RECIST criteria for response


Other Outcome Measures:
  • Overall survival [ Time Frame: 36 months after randomization ]
  • Numbers of patients with adverse events [ Time Frame: Up to 36 months after randomization ]
    According to CTC version 4.0

  • Quality of life [ Time Frame: Up to 36 months after randomization ]
    Measured by questionaires, EORTC QLQ 30 + LC 14


Enrollment: 37
Study Start Date: September 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: November 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664663


Locations
Sweden
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
Sponsors and Collaborators
Ass. Prof. Jan Nyman
Investigators
Principal Investigator: Jan Nyman, Ass. prof Swedish Lung Cancer Study Group
  More Information

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
First Submitted: August 10, 2012
First Posted: August 14, 2012
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:
Radiotherapy
Dose escalation
Normal tissue constraints
Locally advanced disease
Good performance status

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