Concurrent Chemo-radiotherapy With Intensity-Modulated Radiation Therapy (IMRT) for Limited Disease Small Cell Lung Cancer (LD-SCLC)

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:
NCT01166191
First received: July 19, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The investigators' group was the first to perform a phase II trial in patients with limited disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT techniques have become more standard in lung cancer. Because of the lower radiation dose to the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of isolated nodal failures may occur. In this trial, the investigators will investigate the patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage I-III SCLC.


Condition Intervention Phase
Stage I-III 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 Chemo-radiotherapy With IMRT for Stage I-III Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Isolated nodal failures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Proportion of isolated nodal failures 18 months post-radiotherapy


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Dyspnea (CTCAE 4.0) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Dysphagia (CTCAE 4.0) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
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: SCLC Radiation: Radiotherapy
Radiotherapy

Detailed Description:

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45Gy in 30 fractions in 3 weeks (1.5Gy BID). Radiotherapy will be delivered concurrently with cisplatin (or in case of a creatinin clearance of <60ml/min, carboplatin) and etoposide chemotherapy. When after 4 cycles of chemotherapy and concurrent chest radiotherapy, no disease progression is observed and the WHO performance status is 0-2, PCI (prophylactic cranial irradiation) will bee offered to a dose of 25 Gy in 10 daily fractions.

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 of cytological proven SCLC
  • UICC stage I-III, which are amendable for radical local treatment
  • Performance status 0-2
  • IMRT technique

Exclusion Criteria:

  • Not SCLC or mixed SCLC and other histologies (e.g. non-small cell carcinoma)
  • Stage IV
  • 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: NCT01166191

Contacts
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

Locations
Netherlands
MAASTRO clinic Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Dirk De Ruysscher, MD, PhD    +31 88 4455700    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
Investigators
Principal Investigator: Dirk De Ruysscher, MD, PhD Maastro Clinic, The Netherlands
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01166191     History of Changes
Other Study ID Numbers: BRONC 45.1,5
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
SCLC

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

ClinicalTrials.gov processed this record on August 18, 2014