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

Phase 2
18 Years
Open (Enrolling)
Stage I-III Small Cell Lung Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Isolated nodal failures

Outcome Description:

Proportion of isolated nodal failures 18 months post-radiotherapy

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Dirk De Ruysscher, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Netherlands: Dutch Health Care Inspectorate

Study ID:

BRONC 45.1,5



Start Date:

May 2009

Completion Date:

May 2015

Related Keywords:

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