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 is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Maastricht Radiation Oncology
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01166204
First received: July 19, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
  • Dyspnea (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
  • Dysphagia (CTCAE 4.0) [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]
  • Patterns of recurrence [ Time Frame: 2.3 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single group Radiation: Radiotherapy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166204

Locations
Netherlands
MAASTRO clinic Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Dirk De Ruysscher, MD, PhD    +31 88 44 55 700    dirk.deruysscher@maastro.nl   
Contact: Chantal Overhof    +31 88 44 55 686    chantal.overhof@maastro.nl   
Principal Investigator: Dirk De Ruysscher, MD, PhD         
Sponsors and Collaborators
Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01166204     History of Changes
Other Study ID Numbers: BRONC CONCURR MLD/BRONC MLD
Study First Received: July 19, 2010
Last Updated: April 7, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Maastricht Radiation Oncology:
Radiotherapy
NSCLC

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

ClinicalTrials.gov processed this record on August 28, 2014