Adaptive Radiotherapy in Non-small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01207063
First received: July 26, 2010
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

The investigators group uses an individualised radiation dose approach in which the dose is escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is 69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose) constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the investigators will adapt the treatment by performing a new (PET)-CT at day 12 during radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be increased.


Condition Intervention Phase
Non-small Cell Lung Cancer
Other: Radiotherapy and concurrent chemo-therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Proportion of patients able to receive 69Gy as TTD [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Dyspnea (CTCAE 4.0) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Dysphagia (CTCAE 4.0) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patterns of recurrence [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy Other: Radiotherapy and concurrent chemo-therapy
Radiotherapy and concurrent chemo-therapy

Detailed Description:

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.

  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
  • UICC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment
  • 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
  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: NCT01207063

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

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01207063     History of Changes
Other Study ID Numbers: BRONC CONC MLD/BRONC MLD/ADA
Study First Received: July 26, 2010
Last Updated: August 26, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Maastricht Radiation Oncology:
Radiotherapy
NSCLC
Stage II-III non-small cell lung cancer

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

ClinicalTrials.gov processed this record on October 20, 2014