Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans (BRONC 45 15)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 12, 2007 | ||||
| Last Updated Date | June 16, 2009 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
isolated Nodal Recurrences [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00572923 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans | ||||
| Official Title ICMJE | Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans | ||||
| Brief 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. |
||||
| 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 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):
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) |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
|
||||
| Condition ICMJE | Small Cell Lung Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Inclusion criteria
Exclusion criteria:
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 52 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00572923 | ||||
| Other Study ID Numbers ICMJE | BRONC 45, 1.5 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | MAASTRO clinic | ||||
| Study Sponsor ICMJE | Maastricht Radiation Oncology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Maastricht Radiation Oncology | ||||
| Verification Date | June 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||