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

December 8, 2014 updated by: Ass. Prof. Jan Nyman

Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Norrland
      • Umeå, Norrland, Sweden, 901 85
        • Department of Oncology, Norrlands Universitetssjukhus
    • Stockholm county
      • Stockholm, Stockholm county, Sweden, 171 76
        • Department of Oncology, Karolinska University Hospital
    • Västra Götaland
      • Gothenburg, Västra Götaland, Sweden, 413 45
        • Department of Oncology, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 36 monts after randomization
36 monts after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months after randomization
36 months after randomization
Numbers of patients with adverse events
Time Frame: Up to 36 months after randomization
According to CTC version 4.0
Up to 36 months after randomization
Quality of life
Time Frame: Up to 36 months after randomization
Measured by questionaires, EORTC QLQ 30 + LC 14
Up to 36 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ass. Prof. Jan Nyman

Investigators

  • Principal Investigator: Jan Nyman, Ass. prof, Swedish Lung Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLANET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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