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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)

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ClinicalTrials.gov Identifier: NCT01166204
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

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.

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

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
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
Actual Study Start Date : May 2009
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single group Radiation: Radiotherapy
Radiotherapy



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

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


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
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

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


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

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01166204     History of Changes
Other Study ID Numbers: BRONC CONCURR MLD/BRONC MLD
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Maastricht Radiation Oncology:
Radiotherapy
NSCLC

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