Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)
Conditions
Stage I-III Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Radiotherapy, NSCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiotherapy
Type: Radiation
Overall Status
Recruiting
Summary
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
Detailed Description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function.

Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy

In concurrence with chemotherapy, radiotherapy will be delivered as follows:

- First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions

- Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.

In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.

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 third generation schedule is allowed. The type will be registered.

2. Concurrent part: (day 1 = first day of radiotherapy)

- cisplatin - vinorelbine

- cisplatin - docetaxel

- cisplatin - etoposide

- cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles

When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histological or cytological proven NSCLC

- IUCC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment.

- Performance status 0-2

- IMRT technique

Exclusion Criteria:

- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)

- Stage IV, except for solitary (<6) metastases

- Performance status 3 or more

- No IMRT technique
Location
MAASTRO clinic
Maastricht, Limburg, Netherlands
Status: Recruiting
Contact: Dirk De Ruysscher, MD, PhD - +31 88 44 55 700 - dirk.deruysscher@maastro.nl
Start Date
May 2009
Completion Date
May 2015
Sponsors
Maastricht Radiation Oncology
Source
Maastricht Radiation Oncology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page