Clinical trial NCT01166204: 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)
Official title: Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage I-III Non-small Cell Lung Cancer
Keywords: Radiotherapy
NSCLC
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2010-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Overall survival
timeFrame: 2.3 and 5 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2.3 and 5 years
measure: Dyspnea (CTCAE 4.0)
timeFrame: 2.3 and 5 years
measure: Dysphagia (CTCAE 4.0)
timeFrame: 2.3 and 5 years
measure: Patterns of recurrence
timeFrame: 2.3 and 5 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
state: Limburg
Study officials:
References: