Clinical trial · Interventional
Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor
Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Approval of adjuvant durvalumab after RT-CT (not anticipated in the study design) and small number of stage III NSLCL patients with peripheral tumor accessible to SBRT
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor. Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor. The number of patients required in this multicenter prospective study is 70. This is a prospective, multicenter, non comparative and non randomized study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- Study treatment = SBRT for peripheral primary tumor.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- 6 months after the end of SBRT
- description
- According to RECIST v1.1
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years ≤ Age ≤ 75 years * PS ECOG 0 or 1 * Histologically proven NSCLC * Unresectable stage III: T1 or T2 or T3 ≤ 5 cm AND N2 or N3 (only contralateral mediastinum or homolateral supraclavicular). * Peripheral primary tumor ≥ 1 cm and ≤ 5 cm * Possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and Navelbine ® and 3D conformal radiotherapy delivering 66 Gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor. * Adequate biological parameters * Forced expiratory volume (FEV) ≥1 liter or ≥ 30% of the theoretical value * Patient covered by a health insurance scheme * Signed informed consent Exclusion Criteria: * SCLC or large cell neuroendocrine carcinoma * Metastatic disease * Stage IVa * Pregnant or breast-feeding women
References
Publications (0)
Data not yet available