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Non-small Cell Lung CancerPhase 2RTEP7NCT02473133

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

A Phase 2 study testing Personalized dose redistribution and No personalized dose redistribution in people with Non-small Cell Lung Cancer, run by Centre Henri Becquerel at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Personalized dose redistribution and No personalized dose redistribution
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
1 siteFrance
Study dates
12 Nov 2015to 2 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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,
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  • 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.).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

About this study

Official title: 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

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).

Read the detailed description

The investigators objective is to determine whether tumour radiotherapy dose escalated up to 74 Gy in 6.6 weeks can improve the disease Local Regional Control rate at 15 months (1 year after completion of RCT) by adapting radiotherapy target volume to the metabolic response as assessed on FDG-PET/CT performed at 42 Gy of concomitant radio-chemotherapy in stage III non-small cells lung cancer and warrant more extensive phase III study.

Eligible patients will be allocated to one of 2 treatment groups:

  • Arm A: Patients in the experimental arm 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.
  • Arm B: Patients in the standard arm 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).

In both arms, all patients will undergo 2 cycles of induction chemotherapy (based platinum salts) and a curative radio-chemotherapy. In both arms all fields must be treated daily.

Being tested
Personalized dose redistribution, No personalized dose redistribution
Keywords
radiotherapy, dose redistribution, boost
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized dose redistributionRadiation

    Also called boost

    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.

  • No personalized dose redistributionRadiation

    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).

Study groups in NCT02473133
Study groupRoleWhat they receive
Personalized dose redistributionExperimentalPatients 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.
Receives: Radiation: Personalized dose redistribution
No dose redistributionSham comparatorPatients 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).
Receives: Radiation: No personalized dose redistribution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one year

Secondary outcomes (10)

  1. Percentage of local regional control with RECIST 1.1 criteria

    Disease progression will be assessed by RECIST 1.1 criteria

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

  2. interval from the date of registration to date of local or regional progression

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

    Measured: 3 years

  3. 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),

    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),

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

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

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

    Measured: 6.6 weeks

  5. correlation of progression free survival with PET measure

    standardized uptake value max and metabolic tumor volume of FDG -PET2 will be correlated with progression free survival at M15 visit

    Measured: one year

  6. correlation of overall survival with PET measure

    standardized uptake value max and metabolic tumor volume of FDG -PET2 will be correlated with overall survival at M15 visit

    Measured: one year

  7. Change in standardized uptake value max

    Measurements of the relative change in SUVmax from the 18F-FDG -PET1 (baseline) to the FDG -PET2 at 42 Gy defined as [(PET2- PET1) / PET1] x 100%

    Measured: weeks 12

  8. Change in metabolic volume

    Measurements of the relative change metabolic tumour volume from the 18F-FDG -PET1 (baseline) to the FDG -PET2 at 42 Gy defined as [(PET2- PET1) / PET1] x 100%

    Measured: weeks 12

  9. Overall Survival

    overall survival after M9, M15, M27, M39 follow-up visits

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

  10. progression-free survival

    progression-free survival after M9, M15, M27, M39 follow-up visits

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study start12 Nov 2015
  3. Primary completion2 Oct 2024
  4. Study completion2 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473133
Sponsor's protocol ID
CHB14.04/IFCT14-02
Acronym
RTEP7
Status last verified
Dec 2025
First submitted
8 Jun 2015
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Vera P, Giraud P, Hapdey S, Gouel P, Jan O, Le Roux P, Langlais A, Leveque E, Le Tinier F, Olivier A, Martin E, Berriolo-Riedinger A, Pourel N, Broglia JM, Boisselier P, Guillemard S, Salem N, Brenot-Rossi I, Garcia 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, Loo M, Larrouy A, Ghazzar N, Chaumet-Riffaud P, Amour E, Zalcman G, Modzelewski R, Thureau S. Prognostic Value of FDG PET Metabolic Parameters Before and After 42 Gy of Radiochemotherapy in Patients with Inoperable Stage III Nonsmall Cell Lung Cancer. J Nucl Med. 2025 Apr 1;66(4):516-524. doi: 10.2967/jnumed.124.268499.

    PubMed 40015915

  • 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.

    PubMed 39134086

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Personalized dose redistribution and No personalized dose redistribution in people with Non-small Cell Lung Cancer, run by Centre Henri Becquerel at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local regional control rate (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473133, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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