Reduced-target Resection Compared With Full-target Resection After Induction Chemotherapy in Resectable Recurrent Nasopharyngeal Carcinoma: a Multicentre, Randomised, Open-label, Phase 3 Trial
Sponsor study identifier
interventional
424
1 country
1
Study Start
May 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to compare efficacy of two different resection extension in patients with resectable recurrent nasopharyngeal carcinoma after induction chemotherapy. The main question it aims to answer is that whether tumor regress areas after induction chemotherapy required complete resection. Patients will be randomly assigned to receive reduced-target resection or full-target resection after induction chemotherapy. Researchers will compare these two groups to see if the efficacy of reduced-target resection is not inferior to full-target resection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2023
Actual (reported)May 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 26, 2023
Actual (reported)March 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall Survival (OS)
Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened
3 years
The incidence of Severe Adverse events
3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
3 years
In-field recurrence rate
3 years
Progression-free survival (PFS)
3 years
Loco-regional relapse-free survival (LRRFS)
3 years
Patients receive surgery according to pSTV-post-IC and adjuvant immunotherapy.
Patients receive surgery according to pSTV-pre-IC and adjuvant immunotherapy.
Patients receive surgery according to pSTV-post-IC.
Patients receive surgery according to pSTV-pre-IC.
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Ming-Yuan Chen, MD, PhD
Sun Yat-sen University
First Submitted
May 18, 2023
First Posted
May 26, 2023
Study Start
May 20, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 30, 2029
Toripalimab(240 mg d1) continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 26, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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