Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans

Small Cell Lung Cancer Clinical Trial

— BRONC 45 15  

Official title:

Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572923
• Other study ID #: BRONC 45, 1.5
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: June 16, 2009
• Start date: August 2006
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands:Board MAASTRO clinic
• Study type: Observational

Clinical Trial Summary

Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation.

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 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval).

Dose-constraints: MLD > 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.

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.

Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.

Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):

• carboplatin AUC 5 day 1

• etoposide 120 mg/m2 days 1-3

Q 3 weeks; 5 cycles

In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological or cytological proven SCLC

• UICC stage I-III, "limited disease"

• Performance status 0-2

• FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria:

• Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung carcinoma)

• UICC stage IV

• Performance status 3 or more

• FeV 1 and DLCO < 30% of the age-predicted value

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic, Maastricht Radiation Oncology	Maastricht

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 Recurrences		18 months post-treatment	No
Secondary	overall survival		18 months post-treatment	No
Secondary	progression-free interval		18 months post-treatment	No
Secondary	dyspnea (CTCAE 3.0)		18 months post-treatment	No
Secondary	dysphagia (CTCAE 3.0)		18 months post-treatment	No
Secondary	patterns of recurrence		18 months post-treatment	No