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

NCT01282450 | Completed Phase 2

• 1 other identifier: Oligometa's
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage IV (Oligo-metastases); Non-small Cell Lung Cancer

Keywords

Radiotherapy; NSCLC

Outcome Measures

Primary Outcomes (2)

• Overall survival

  The survival of participating patient two years after entering the study

  2 years

• Overall survival

  The survival of participating patients, three years after entering the study.

  3 years

Secondary Outcomes (8)

• Progression free survival

  2 years

• Dyspnea (CTC4.0)

  2 years

• Dysphagia (CTC 4.0)

  2 years

• Patterns of recurrence

  2 years

• Progression free survival

  3 years

Study Arms (1)

Single arm

EXPERIMENTAL

Eligible patients

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Radiotherapy

Also known as: Radiotherapy with or without surgery or chemotherapy

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

Related Publications (1)

• De Ruysscher D, Wanders R, van Baardwijk A, Dingemans AM, Reymen B, Houben R, Bootsma G, Pitz C, van Eijsden L, Geraedts W, Baumert BG, Lambin P. Radical treatment of non-small-cell lung cancer patients with synchronous oligometastases: long-term results of a prospective phase II trial (Nct01282450). J Thorac Oncol. 2012 Oct;7(10):1547-55. doi: 10.1097/JTO.0b013e318262caf6.

  PMID: 22982655 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy; Surgical Procedures, Operative; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dirk De Ruysscher, MD, PhD

  MAASTRO clinic, Maastricht Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: January 25, 2011
• Study Start: May 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

NL (1)