A Phase 2 interventional study of mid-position radiation strategy and ITV in Non-small Cell Lung Cancer, Radiation Therapy and Locally Advanced Disease, sponsored by Centre Leon Berard. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Centre Leon Berard · Phase 2, Interventional, and Treatment
The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.
6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 54 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Centre Leon Berard is the lead sponsor of 210 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Patients treated with midP radiotherapy strategy.
Radiation: mid-position radiation strategy
Patient treated with radiotherapy ITV strategy
Radiation: ITV
The midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy
The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.
1 year Progression Free Survival rate
Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy
Time frame: 1 year
Local tumor control rate
Time frame: 1 year and 2 years after the end of irradiation
Overall survival
Time frame: 1 year and 2 years post irradiation
To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration
Time frame: Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning
Ran from Sep 2012 to primary completion in Aug 2020, 95 months.
Of 678 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 81. This study's 95 months is above that.
Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →