Non-small Cell Lung Cancer Clinical Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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