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

Primary Purpose

Stage I-III Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Maastricht Radiation Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I-III Small Cell Lung Cancer focused on measuring Radiotherapy, SCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MAASTRO clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCLC

Arm Description

Outcomes

Primary Outcome Measures

Isolated nodal failures
Proportion of isolated nodal failures 18 months post-radiotherapy

Secondary Outcome Measures

Progression-free survival
Dyspnea (CTCAE 4.0)
Dysphagia (CTCAE 4.0)
Overall survival

Full Information

First Posted
July 19, 2010
Last Updated
May 22, 2017
Sponsor
Maastricht Radiation Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01166191
Brief Title
Concurrent Chemo-radiotherapy With Intensity-Modulated Radiation Therapy (IMRT) for Limited Disease Small Cell Lung Cancer (LD-SCLC)
Official Title
Concurrent Chemo-radiotherapy With IMRT for Stage I-III Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht Radiation Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I-III Small Cell Lung Cancer
Keywords
Radiotherapy, SCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCLC
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy
Primary Outcome Measure Information:
Title
Isolated nodal failures
Description
Proportion of isolated nodal failures 18 months post-radiotherapy
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
18 months
Title
Dyspnea (CTCAE 4.0)
Time Frame
18 months
Title
Dysphagia (CTCAE 4.0)
Time Frame
18 months
Title
Overall survival
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ruysscher, MD, PhD
Organizational Affiliation
Maastro Clinic, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAASTRO clinic
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ET
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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