Clinical trial · Interventional
Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Patients With Stage III Non-small-cell Lung Cancer
Phase II Study of the Efficacy and Safety of a Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Identified by F-miso PET/CT in Patients With Stage III Non-small-cell Lung Cancer (NSCLC) Not Amenable to Curative Surgical Resection Who Are Candidate for Curative Radio-chemotherapy
- 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)
This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy. Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach. The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.
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 |
|---|---|---|---|
| Stage III Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the rate of local control
- timeFrame
- 3 month
- description
- to evaluate the rate of local control after dose complement in hypoxic lesions \[maximum dose without the fraction of total lung volume receiving more that 20 Gy exceeding 30% of the lung (V20)\], as determined by F-miso PET/CT.
Secondary outcomes (4)
- measure
- 3 months and 1 year toxicity
- timeFrame
- 1 year
- description
- 3 months and 1 year toxicity measured according CTCAE 4.0
- measure
- Percentage of patients for whom the RT dose could be increased
- timeFrame
- 3 years
- description
- Percentage of patients for whom the RT dose could be increased
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with stage III non-small-cell lung cancer candidate for curative radio-chemotherapy * The final inclusion is granted after completion of a dosimetric study confirming that the dose objectives (minimum dose of 60 Gy in 99% of target volume) and constraints to organs at risk can be achieved. Exclusion Criteria: * Other cancer * no evaluable tumor target * Absence of binding to FDG-PET tests before primary chemotherapy * Patients for which radiotherapy with curative intent is not indicated * History of neoplastic disease of less than 5 years or progressive * Patient already included in another clinical trial * Pregnant, likely to be or during breastfeeding * performance index OMS ≥2 * Indicating renal insufficiency against Cisplatin treatment * Protected adults * Unable to submit to medical study for reasons geographical, social or physical * Patients with poorly controlled diabetes blood sugar ≥10 mmol/L * hypersensitivity to FDG or any excipients of the radiopharmaceutical * hypersensitivity to Fmiso or any excipients of the radiopharmaceutical * Patients unable to understand the study (language ...) * Patients not affiliated to the "sécurité social"
References
Publications (3)
- DERIVEDGanem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2. PMID 30419929
- DERIVEDThureau S, Dubray B, Modzelewski R, Bohn P, Hapdey S, Vincent S, Anger E, Gensanne D, Pirault N, Pierrick G, Vera P. FDG and FMISO PET-guided dose escalation with intensity-modulated radiotherapy in lung cancer. Radiat Oncol. 2018 Oct 23;13(1):208. doi: 10.1186/s13014-018-1147-2. PMID 30352608
- DERIVEDVera P, Thureau S, Chaumet-Riffaud P, Modzelewski R, Bohn P, Vermandel M, Hapdey S, Pallardy A, Mahe MA, Lacombe M, Boisselier P, Guillemard S, Olivier P, Beckendorf V, Salem N, Charrier N, Chajon E, Devillers A, Aide N, Danhier S, Denis F, Muratet JP, Martin E, Riedinger AB, Kolesnikov-Gauthier H, Dansin E, Massabeau C, Courbon F, Farcy Jacquet MP, Kotzki PO, Houzard C, Mornex F, Vervueren L, Paumier A, Fernandez P, Salaun M, Dubray B. Phase II Study of a Radiotherapy Total Dose Increase in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients with Non-Small Cell Lung Carcinoma (RTEP5 Study). J Nucl Med. 2017 Jul;58(7):1045-1053. doi: 10.2967/jnumed.116.188367. Epub 2017 Mar 2. PMID 28254869