Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Patients With Stage III Non-small-cell Lung Cancer (RTEP-5)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Evaluate the rate of local control [ Time Frame: 3 month ] [ Designated as safety issue: No ]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.
- 3 months and 1 year toxicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]3 months and 1 year toxicity measured according CTCAE 4.0
- Percentage of patients for whom the RT dose could be increased [ Time Frame: 3 years ] [ Designated as safety issue: No ]Percentage of patients for whom the RT dose could be increased
- Simultaneous variation of the glucose metabolism and hypoxia during radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]comparaison of both exam PETscan FDG and PETscan FMISO performed during radiotherapy
- Predictive value on 1-year survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]Predictive value on 1-year survival probability of the variations in glucose metabolism and hypoxia during radiotherapy
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
- Radiation therapy is conducted under standard conditions of conformal radiotherapy:
- The total dose was 66-70 Gy delivered in daily fractions of 2 Gy, 5 days a-week
No additional dose (patients negative F-miso)
With additional dose (patients positive for F-miso)
The dose in the PTVmiso increased until the maximum tolerable radiation by the lung.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576796
|Contact: Pierre VERA, university professor||232082497 ext firstname.lastname@example.org|
|Contact: Olivier RASTELLI, study coordinator||232082900 ext email@example.com|
|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76000|
|Principal Investigator: Pierre VERA, PhD- HP|
|Sub-Investigator: Agathe Edet-Sanson, HP|
|Sub-Investigator: bernard DUBRAY, pHD - HP|
|Sub-Investigator: Sebastien THUREAUX, HP|