NCT02473133CompletedPhase 2
Study of Interest of Personalized Radiotherapy Dose Redistribution in Patients With Stage III NSCLC
Randomized Phase II-III Study of Personalized Radiotherapy Dose Redistribution in Patients With Inoperable Stage III Non-small Cell Lung Cancer and a Persistent FDG Uptake at 42 Grays During Concomitant Radio-chemotherapy
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
In patients with locally advanced stage III non-small cell lung cancer, the probability of local control remains low (about 17% at 1 year). Concomitant radio-chemotherapy is the standard treatment. An increase in total radiotherapy dose (from 66 to 74 Gray) has been proposed to improve local control, with contradictory results. Relevant FDG-PET scan images can be acquired during radio-chemotherapy, with a demonstrated prognostic impact and recently in a multicentre prospective study. A significant reduction in FDG uptake / volume (metabolic response) suggests that the radiotherapy target volume could be reduced during radiotherapy possibly improving organs at risk tolerance. Conversely, a lack of metabolic response may justify treatment intensification before the end of radiotherapy. The investigators hypothesis is to investigate the individual tumour heterogeneity on FDG-PET during radio-chemotherapy to reduce the volume to a biological target that could receive a higher total dose (personalized dose redistribution).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 158 (actual)
- First submitted
- 8 Jun 2015
- Start date
- 12 Nov 2015
- Primary completion date
- 2 Oct 2024
- Lead sponsor
- Centre Henri Becquerel
- Diseases
- Lung cancer
- NCT number
- NCT02473133
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 158
- From 12 Nov 2015 to the primary completion date, 2 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absence of FDG uptake on FDG-PET/CT scan before induction chemotherapy,
- Previous neoplastic disease of less than 5 years duration or progressive (without basal cell carcinoma of the skin, in situ carcinoma of the cervix),
- Previous thoracic radiotherapy,
Other illness
- Histology other than non-small cell lung cancer,
- Patients for whom curative radiotherapy is not indicated (tumour extension, metastases, general condition, co-morbidities),
- Significant interstitial disease on CT scan,
- Hypersensitivity to the active substance (FDG) or to any of the excipients,
Lab values
- Uncontrolled diabetes with blood glucose ≥10 mmol/L,
Other
- Patient enrolled in another therapeutic trial,
- Pregnant women or women of child-bearing potential or breast feeding mothers,
- Adult subjects who are under protective custody or guardianship,
- Patient unable to comply with the specific obligations of the study (geographic, social or physical reasons),
- Patients unable to understand the purpose of the study (language, etc.).
Who the study is looking for
- Male or female patients,
- Age over 18 years and below 75-year-old,
- Good general condition: WHO performance status ≤ 1,
- Histological evidence of non-small cell lung cancer,
- Measureable tumour according to RECIST 1.1 evaluation criteria,
- Mediastinoscopy or endobronchial ultrasound to prove the histological stage N2/N3,
- Patient eligible to curative-intent radio-chemotherapy,
- Absence of pleural involvement, of pulmonary or extra-thoracic metastatic localisation,
- Absence of co-morbidity contra-indicating radio-chemotherapy,
- Lung function: FEV1 ≥ 40% of theoretical value and DLCO/VA ≥ 60% of theoretical value and PaO2 ≥ 60 mm Hg,
- Tumour FDG uptake higher than mediastinal background noise on baseline PET/CT,
- Haematological parameters:
- Neutrophil count ≥ 1.5x109/L and platelet count ≥ 100x109/L,
- Haemoglobin ≥ 9 g/dL,
- Provisional RT plan confirming that the dose objectives (minimal dose of 62.7 Gy (95% of the prescribed dose) in 98% of target volumes and 70.3 Gy for the "boosted" volume at 74 Gy) and constraints (lungs, spinal cord) are met (ICRU83),
- Estimated creatinine clearance ≥ 60 mL/min,
- Signed informed consent
- Affiliated or beneficiary of a social benefit system
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.