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

18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:


Outcome Time Frame:

2,3 and 5 years

Safety Issue:


Principal Investigator

Dirk De Ruysscher, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MAASTRO clinic, Maastricht Radiation Oncology


Netherlands:Board MAASTRO clinic

Study ID:




Start Date:

August 2006

Completion Date:

May 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • radiotherapy
  • stage III non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms