Clinical trial · Interventional
Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma
Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).
NCT01635270CI-TRIAL-00049894midPcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Disease | — | UNRESOLVED | — |
| Non-metastatic Disease | — | UNRESOLVED | — |
| Non-resectable Disease | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ITV | Radiation | — | UNRESOLVED |
| mid-position radiation strategy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- midP arm
- description
- Patients treated with midP radiotherapy strategy.
- interventionNames
- Radiation: mid-position radiation strategy
- type
- ACTIVE_COMPARATOR
- label
- ITV arm
- description
- Patient treated with radiotherapy ITV strategy
- interventionNames
- Radiation: ITV
Primary outcomes (1)
- measure
- 1 year Progression Free Survival rate
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion * Age \>= 18 years * PS \<=2 * CT-scan within 3 months at inclusion * PET-scan within 3 months at inclusion * Respiratory functional exploration within 3 months at inclusion * estimated V20 (by radiotherapist)\< 35% on conventional pre-radiotherapy imaging * Tumor T0 to T4, M0; N1, N2 ou N3 by isolateral supra-clavicular involvement * Measurable disease according to RECIST criteria 1.1 * Curative intent Chest conventional radiation therapy * Radiation indication validated by a multidisciplinary meeting * Adequate contraceptive method for the whole study duration and for up to 28 days after the end of radiation * Mandatory affiliation with a health insurance company * Patients must provide dated \& written consent Exclusion Criteria: * Prior surgery for NSCLC * NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion * Metastatic disease or N3 contralateral lymph node * History of chest irradiation * History of known increased intrinsic radiosensibility * Hypersensibility to active substance or excipient of fluoro-deoxyglucose-18F * Life expectancy \< 6 months * Patient with a concurrent malignancy or with a history of malignancy (excepted adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or other malignancies free of the disease for at least 5 years) * Pregnant or breastfeeding women * Psychological, sociological or geographical conditions that would limit compliance with study requirements * Patient deprived of freedom * Patient has concomitant participation to an other investigational study
References
Publications (0)
Data not yet available
No reference posted for this study.