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

This study has been completed.
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00572325
First received: December 12, 2007
Last updated: July 20, 2010
Last verified: July 2010
  Purpose

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


Condition
Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Concurrent Chemo-radiotherapy for Stage III Non-small Cell Lung Cancer ta an Individualized MLD

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • death [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: August 2006
Study Completion Date: May 2009
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572325

Locations
Netherlands
MAASTRO clinic, Maastricht Radiation Oncology
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Dirk De Ruysscher, MD,PhD MAASTRO clinic, Maastricht Radiation Oncology
  More Information

No publications provided by Maastricht Radiation Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MAASTRO clinic
ClinicalTrials.gov Identifier: NCT00572325     History of Changes
Other Study ID Numbers: BRONC CONCURR MLD
Study First Received: December 12, 2007
Last Updated: July 20, 2010
Health Authority: Netherlands:Board MAASTRO clinic

Keywords provided by Maastricht Radiation Oncology:
radiotherapy
NSCLC
stage III non-small cell lung cancer

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 August 28, 2014