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

Maastricht Radiation Oncology

Status: Completed

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00572325

BRONC CONCURR MLD

Details and patient eligibility

About

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

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

1

Description:

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