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

Stage I-III Small Cell Lung Cancer Clinical Trial

Official title:

Concurrent Chemo-radiotherapy With IMRT for Stage I-III Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166191
• Other study ID #: BRONC 45.1,5
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2010
• Last updated: May 22, 2017
• Start date: May 2009
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Stage I-III Small Cell Lung Cancer

Intervention

Radiation:
• Radiotherapy
Radiotherapy

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isolated nodal failures	Proportion of isolated nodal failures 18 months post-radiotherapy	18 months
Secondary	Progression-free survival		18 months
Secondary	Dyspnea (CTCAE 4.0)		18 months
Secondary	Dysphagia (CTCAE 4.0)		18 months
Secondary	Overall survival		18 months