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)

NCT ID: NCT01166204

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2017-05-31

Brief 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

Conditions

Stage I-III Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single group

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Radiotherapy

Interventions

Radiotherapy

Radiotherapy

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MAASTRO clinic

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

BRONC CONCURR MLD/BRONC MLD

Identifier Type: -

Identifier Source: org_study_id