Concurrent Chemo-radiation Form NSCLC to a Individualized MLD (BRONC CONC MLD)

July 20, 2010 updated by: Maastricht Radiation Oncology

Concurrent Chemo-radiotherapy for Stage III Non-small Cell Lung Cancer ta an Individualized MLD

Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy

Study Overview

Status

Completed

Conditions

Detailed Description

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):

  • MLD=19 Gy when Fev1 and DLCO>50% of the predicted value
  • MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
  • MLD=10 Gy when Fev1 and/or DLCO <40% of the predicted value

Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:54 Gy. Maximal tumor dose:69 Gy

Radiotherapy will be delivered as follows:

  1. First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
  2. Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Chemotherapy schedules allowed:

  1. 1-2 cycles induction chemotherapy; any type will be registered.

  2. concurrent part:(day1= first day of radiotherapy)

    1. cisplatin - vinorelbine

      • Cisplatin 50 mg/m2 day 2 and day 9
      • Vinorelbine 20 mg/m2 day 2 and day 9
      • Cisplatin 40mg/m2 day 23
      • Vinorelbine 15mg/m2 day 23 and day 30

    2. cisplatin - docetaxel

      • Cisplatin 50 mg/m2 day 2,9 and 29
      • Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29

    3. cisplatin - etoposide

      • Cisplatin 60 mg/m2 day 1
      • Docetaxel 120 mg/m2 day 1-3

Q 3 weeks, 3 cycles

When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin

Study Type

Observational

Enrollment (Actual)

180

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

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • MAASTRO clinic, Maastricht Radiation Oncology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Histological or cytological proven NSCLC
  • UICC stage I-III
  • Performance status 0-2
  • FeV 1 and DLCO at least 30% of the age-predicted value

Description

Inclusion Criteria:

  • Histological or cytological proven NSCLC
  • UICC stage I-III
  • Performance status 0-2
  • FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria:

  • Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
  • UICC stage IV
  • Performance status 3 or more
  • FeV 1 and DLCO < 30% of the age-predicted value

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

Cohorts and Interventions

Group / Cohort
1

Inclusion criteria

  • Histological or cytological proven NSCLC
  • UICC stage I-III
  • Performance status 0-2
  • FeV1 and DLCO at least 30% of age-predicted value

Exclusion criteria:

  • Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
  • stage IV
  • performance status 3 or more
  • FeV 1 or DLCO< 30% of the age-predicted value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 2,3 and 5 years
2,3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence
Time Frame: 2,3 and 5 years
2,3 and 5 years

Collaborators and Investigators

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

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Dirk De Ruysscher, MD,PhD, MAASTRO clinic, Maastricht Radiation Oncology

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

August 1, 2006

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

July 21, 2010

Last Update Submitted That Met QC Criteria

July 20, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRONC CONCURR MLD

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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