Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An open-label, multi-center, randomized phase III trial comparing safety and efficacy of personalized vs non-personalized radionuclide therapy with 177Lu-DOTATOC

Conditions

neuroendocrine tumours

Brief summary

Median PFS defined as time from randomization to radiological progression, or death from any cause

Detailed description

Rate of treatment-related adverse reactions graded according to CTCAE v5.0, Median OS defined as time from randomization to death from any cause, Median PFS defined as time from randomization to radiological progression, or death from any cause, Percent change in SLD from baseline to time of best response, EORTC QoL-questionnaires GI-NET21, Cumulative median AD to target tumor lesions in subjects with CR, PR, SD and PD as best response, according to RECIST evaluations, Correlation between cumulative median AD to target tumor lesions and time to progression, defined as time from randomization to radiological progression., Cumulative median AD and BED to kidneys vs rate of grade 3-4 renal toxicity (estimated and measured GFR), Differences in resource utilization and treatment cost between the two treatment arms, in relation to the respective mPFS and mOS.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUG177Lu-Edotreotide

DRUGCAPECITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Median PFS defined as time from randomization to radiological progression, or death from any cause	—

Secondary

Measure	Time frame
Rate of treatment-related adverse reactions graded according to CTCAE v5.0, Median OS defined as time from randomization to death from any cause, Median PFS defined as time from randomization to radiological progression, or death from any cause, Percent change in SLD from baseline to time of best response, EORTC QoL-questionnaires GI-NET21, Cumulative median AD to target tumor lesions in subjects with CR, PR, SD and PD as best response, according to RECIST evaluations, Correlation between cumulative median AD to target tumor lesions and time to progression, defined as time from randomization to radiological progression., Cumulative median AD and BED to kidneys vs rate of grade 3-4 renal toxicity (estimated and measured GFR), Differences in resource utilization and treatment cost between the two treatment arms, in relation to the respective mPFS and mOS.	—

Measure

Time frame

Rate of treatment-related adverse reactions graded according to CTCAE v5.0, Median OS defined as time from randomization to death from any cause, Median PFS defined as time from randomization to radiological progression, or death from any cause, Percent change in SLD from baseline to time of best response, EORTC QoL-questionnaires GI-NET21, Cumulative median AD to target tumor lesions in subjects with CR, PR, SD and PD as best response, according to RECIST evaluations, Correlation between cumulative median AD to target tumor lesions and time to progression, defined as time from randomization to radiological progression., Cumulative median AD and BED to kidneys vs rate of grade 3-4 renal toxicity (estimated and measured GFR), Differences in resource utilization and treatment cost between the two treatment arms, in relation to the respective mPFS and mOS.

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Countries

Sweden

Outcome results

None listed