Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Patients With Stage III Non-small-cell Lung Cancer (RTEP-5)
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|ClinicalTrials.gov Identifier: NCT01576796|
Recruitment Status : Unknown
Verified July 2016 by Centre Henri Becquerel.
Recruitment status was: Active, not recruiting
First Posted : April 12, 2012
Last Update Posted : July 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage III Non-small-cell Lung Cancer||Radiation: Radiotherapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||June 2017|
- Radiation: Radiotherapy
No additional dose (patients negative F-miso)
- 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
With additional dose (patients positive for F-miso)
The dose in the PTVmiso increased until the maximum tolerable radiation by the lung.
- Evaluate the rate of local control [ Time Frame: 3 month ]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 ]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 ]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 ]comparaison of both exam PETscan FDG and PETscan FMISO performed during radiotherapy
- Predictive value on 1-year survival [ Time Frame: 1 year ]Predictive value on 1-year survival probability of the variations in glucose metabolism and hypoxia during radiotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576796
|Centre Henri Becquerel|
|Rouen, France, 76000|