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Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer

Eligible patients will receive concurrent chemo-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 concurrent with chemotherapy, radiotherapy will be delivered as follows:

1. 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.

2. 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)

1. cisplatin-vinorelbine

2. cisplatin-docetaxel

3. cisplatin-etoposide

4. cisplatin-pemetrexed in non-squamous histologies

Q3 week; 3 cycles

When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted
for carboplatin.

In case the TTD(Total Treatment Dose)=69Gy cannot be reached because of a limiting MLD, a
FDG-PET-CT will be performed at day 12 during radiotherapy. GTV's (Gross Tmor Volume), CTV's
(Clinical Target Volume) and PTV's (Planning Target Volume) will be delineated and a new
plan calculated. The endpoint will be the proportion of patients that will receive 69Gy.

Inclusion Criteria:

- Histological or cytological proven NSCLC

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

- Performance status 0-2

- IMRT technique

Exclusion Criteria:

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

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

- Performance status 3 or more

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients able to receive 69Gy as TTD

Outcome Time Frame:

3 months

Safety Issue:



Netherlands: Dutch Health Care Inspectorate

Study ID:




Start Date:

March 2011

Completion Date:

July 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Radiotherapy
  • Stage II-III non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms