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NCT Number: NCT00572325

Concurrent Chemo-radiation Form NSCLC to a 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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MAASTRO clinic, Maastricht Radiation Oncology

Maastricht, 6202 AZ, Netherlands

About this study

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:

  • 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
  • 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:

  • 1-2 cycles induction chemotherapy; any type will be registered.
  • concurrent part:(day1= first day of radiotherapy)
  • 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
  • cisplatin - docetaxel
  • Cisplatin 50 mg/m2 day 2,9 and 29
  • Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. death

    Time frame: 2,3 and 5 years

Secondary outcomes

  1. -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence

    Time frame: 2,3 and 5 years

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

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

Acronym: BRONC CONC MLD

Important dates

Study start
2006
Study completion
2009
First posted
Dec 13, 2007
Registry last updated
Jul 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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