Study of Interest of Personalized Radiotherapy Dose Redistribution in Patients With Stage III NSCLC

NCT02473133 | Completed Phase 2 DMC

• 1 other identifier: CHB14.04/IFCT14-02
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Non-small Cell Lung Cancer

Keywords

radiotherapy; dose redistribution; boost

Outcome Measures

Primary Outcomes (1)

• Local regional control rate

  LCR rate (responders or stable disease) at 1 year after completion of RCT (M15 visit). Disease progression will be assessed by RECIST 1.1 criteria

  one year

Secondary Outcomes (10)

• Percentage of local regional control with RECIST 1.1 criteria

  assessed at 9 months, 15 months, 27 months and 39 months

• interval from the date of registration to date of local or regional progression

  3 years

• Percentage of severe (grade 3+ CTCAE, v4) radiation-induced toxicity affecting lung and oesophagus at M9 visit (early toxicity) and M15, M27, M39 visits (late toxicity),

  assessed at 9 months, 15 months, 27 months and 39 months

• Percentage of patients in arm A for whom the radiotherapy dose could be increased

  6.6 weeks

• correlation of progression free survival with PET measure

  one year

Study Arms (2)

Personalized dose redistribution

EXPERIMENTAL

Patients in the will receive an individualized radiotherapy prescription up to a total dose of 74 Gy given in 6.6 weeks if they have a positive FDG-PET at 42Gy (about two thirds of patients are expected as positive). An initial dose of 50 Gy will be delivered in 5 weeks (single daily fractions of 2 Gy), then an additional dose up to 24 Gy will be delivered over 1.6 week using a twice-a-day fractionated radiotherapy.

Radiation: Personalized dose redistribution

No dose redistribution

SHAM COMPARATOR

Patients will receive a single prescription of 66 Gy in 33 fractions in 6.6 weeks, with 2 Gy fractions given once daily, 5 days a week, without target volume reduction or adaptation (whatever the FDG-PET result).

Radiation: No personalized dose redistribution

Interventions

Personalized dose redistribution RADIATION

Patients will receive an individualized radiotherapy prescription up to a total dose of 74 Gy given in 6.6 weeks if they have a positive FDG-PET at 42Gy. An initial dose of 50 Gy will be delivered in 5 weeks (single daily fractions of 2 Gy), then an additional dose up to 24 Gy will be delivered over 1.6 week.

Also known as: boost

Personalized dose redistribution

No personalized dose redistribution RADIATION

Patients will receive a single prescription of 66 Gy in 33 fractions in 6.6 weeks, with 2 Gy fractions given once daily, 5 days a week, without target volume reduction or adaptation (whatever the FDG-PET2 result).

No dose redistribution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• Histology other than non-small cell lung cancer,
• Absence of FDG uptake on FDG-PET/CT scan before induction chemotherapy,
• Patients for whom curative radiotherapy is not indicated (tumour extension, metastases, general condition, co-morbidities),
• Significant interstitial disease on CT scan,
• 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,
• 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),
• Uncontrolled diabetes with blood glucose ≥10 mmol/L,
• Hypersensitivity to the active substance (FDG) or to any of the excipients,
• Patients unable to understand the purpose of the study (language, etc.).

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: collaborator
• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

Related Publications (1)

• Vera P, Thureau S, Le Tinier F, Chaumet-Riffaud P, Hapdey S, Kolesnikov-Gauthier H, Martin E, Berriolo-Riedinger A, Pourel N, Broglia JM, Boissellier P, Guillemard S, Salem N, Brenot-Rossi I, Le Pechoux C, Berthold C, Giroux-Leprieur E, Moreau D, Guillerm S, Benali K, Tessonnier L, Audigier-Valette C, Lerouge D, Quak E, Massabeau C, Courbon F, Moisson P, Larrouy A, Modzelewski R, Gouel P, Ghazzar N, Langlais A, Amour E, Zalcman G, Giraud P. Adaptive radiotherapy (up to 74 Gy) or standard radiotherapy (66 Gy) for patients with stage III non-small-cell lung cancer, according to [18F]FDG-PET tumour residual uptake at 42 Gy (RTEP7-IFCT-1402): a multicentre, randomised, controlled phase 2 trial. Lancet Oncol. 2024 Sep;25(9):1176-1187. doi: 10.1016/S1470-2045(24)00320-6. Epub 2024 Aug 9.

  PMID: 39134086 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peirre Vera, MD,PHD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 16, 2015
• Study Start: November 12, 2015
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)