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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01166191
Enrollment
60
Registered
2010-07-20
Start date
2009-05-31
Completion date
2017-05-31
Last updated
2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage I-III Small Cell Lung Cancer

Keywords

Radiotherapy, SCLC

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.

Interventions

RADIATIONRadiotherapy

Radiotherapy

Sponsors

Maastricht Radiation Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Isolated nodal failures18 monthsProportion of isolated nodal failures 18 months post-radiotherapy

Secondary

MeasureTime frame
Progression-free survival18 months
Dyspnea (CTCAE 4.0)18 months
Dysphagia (CTCAE 4.0)18 months
Overall survival18 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026