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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01166191
First Posted: July 20, 2010
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht Radiation Oncology
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    Proportion of isolated nodal failures 18 months post-radiotherapy


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 18 months ]
  • Dyspnea (CTCAE 4.0) [ Time Frame: 18 months ]
  • Dysphagia (CTCAE 4.0) [ Time Frame: 18 months ]
  • Overall survival [ Time Frame: 18 months ]

Enrollment: 60
Actual Study Start Date: May 2009
Study Completion Date: May 2017
Primary Completion Date: May 2017 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166191


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, The Netherlands
  More Information

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01166191     History of Changes
Other Study ID Numbers: BRONC 45.1,5
First Submitted: July 19, 2010
First Posted: July 20, 2010
Last Update Posted: May 23, 2017
Last Verified: May 2017

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