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Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01282450
First received: December 6, 2010
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

In recent years, it has become clear, that also in non-small cell lung cancer (NSCLC), a group of patients with less than 5 distant metastases may experience long-term survival when treated radically to all macroscopic cancer sites. Thus has mostly been established for individuals with so-called solitary brain metastases and to a lesser extend in solitary adrenal gland metastases, but in other metastatic subgroups, the same may be applicable. In a prospective survey in the region of the Integral Cancercentre (IKL), we could identify on a yearly base 30 patients with NSCLC who could theoretically be amendable for radical treatment of all oligo-metastatic locations. We therefore want to perform a prospective study in which patients with less than 4 oligo-metastatic sites from a primary NSCLC will be treated radically with the aim to improve long-term survival. As many discussion points remain, even after thorough discussions with chest physicians, pulmonary surgeons and colleagues from diagnostic disciplines, we decided to go for a pragmatic approach, implying that all macroscopic disease sites should be treated radically, being defined as surgery with a R0 resection or in case of an unforeseen R1 resection, followed by radiotherapy, or radiotherapy to a biological equivalent of at least 60 Gy in 30 daily fractions. In the same patient, one metastatic site may be treated with surgery and another with radical radiotherapy. Systemic treatment was not made mandatory, because it was felt that it's role is unclear in patients with early stage local cancer and with oligo-metastatic disease.


Condition Intervention Phase
Stage IV (Oligo-metastases)
Non-small Cell Lung Cancer
 Radiation: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC).

Resource links provided by NLM:

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

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The survival of participating patient two years after entering the study

  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The survival of participating patients, three years after entering the study.


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Dyspnea (CTC4.0) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Dysphagia (CTC 4.0) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Patterns of recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Dyspnea (CTC4.0) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Dysphagia (CTC4.0) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Patterns of recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
Eligible patients
 Radiation: Radiotherapy
Radiotherapy
Other Name: Radiotherapy with or without surgery or chemotherapy

Detailed Description:

Eligible patients (see below) will receive radical 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 and/or to all metastatic sites to a minimal biological equivalent of 60Gy in 30 daily fractions. This may be delivered with hypofractionated stereotactic techniques or with other more protracted fractionation regimen.

Both the primary tumor, the regional N1 lymph nodes and the oligo-metastatic site(s) may be treated with surgery, as long as an R0 resection is deemed possible. Systemic treatment is not required, but should be given according to the local extend of the tumor.

Local radiotherapy will be delivered according to the protocol of MAASTRO clinic for that anatomical site.

Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax): 66Gy 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.

  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 IV, or solitary metastases (< 5), which are amendable for radical local treatment
  • Performance status 0-2
  • Other malignancy is allowed if controlled at the point of diagnosis

Exclusion Criteria:

  • Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
  • Stage I-III, except for T4 because of pleural metastases
  • Performance status 3 or more
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282450

Locations
Netherlands
MAASTRO clinic
Maastricht, Limburg, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Dirk De Ruysscher, MD, PhD MAASTRO clinic, Maastricht Radiation Oncology
  More Information

No publications provided by Maastricht Radiation Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MAASTRO clinic
ClinicalTrials.gov Identifier: NCT01282450     History of Changes
Other Study ID Numbers: Oligometa's
Study First Received: December 6, 2010
Last Updated: July 18, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
Radiotherapy
NSCLC

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

ClinicalTrials.gov processed this record on May 19, 2013