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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)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 20, 2010
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht Radiation Oncology
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.

Condition Intervention Phase
Stage I-III Non-small Cell Lung Cancer Radiation: Radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2.3 and 5 years ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2.3 and 5 years ]
  • Dyspnea (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ]
  • Dysphagia (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ]
  • Patterns of recurrence [ Time Frame: 2.3 and 5 years ]

Enrollment: 300
Actual Study Start Date: May 2009
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single group Radiation: Radiotherapy

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166204

MAASTRO clinic
Maastricht, Limburg, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
  More Information

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01166204     History of Changes
First Submitted: July 19, 2010
First Posted: July 20, 2010
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Maastricht Radiation Oncology:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms