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NCT04898374

Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma

Recruiting now Phase 3 Last updated 17 August 2022
What this trial tests

Phase 3 trial testing Gemcitabin/cisplatin in Nasopharyngeal Carcinoma in 120 participants. Currently enrolling.

Timeline
1 May 2021
Primary endpoint
30 April 2025
30 April 2026

Quick facts

Lead sponsorKuwait Cancer Control Center
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment120
Start date1 May 2021
Primary completion30 April 2025
Estimated completion30 April 2026
Sites1 location across Kuwait

Drugs / interventions tested

Conditions studied

Sponsor

Kuwait Cancer Control Center — full company profile →

Who can join

Adults 18 to 70, any sex, with Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The standard of care for locally advanced nasopharyngeal carcinoma is radical chemoradiation(CRT).Recent advances in radiation techniques and supportive measures resulted in improvemnent of locoregional control and quality of life.However distant failure is still the main challenging reason of poor survival Addition of systemic therapy to concurrent CRT is widely used and accepted as an option to reduce these failures ,however selection of chemotherapy regimen and timing in relation to CRT is controversial. Doublet and triplet chemotherapy regimens using cisplatin and 5FU are throughly investigated in this setting.Inspite of significant improvement in disease free survival and overall survival they were poorly tolerated.Hence,minority of patients in the daily practice could tolerate those studied regimens as propsed. Recently, in multicenter randomized trial, Zhang and his group investigated gemcitabine and cisplatin as induction chemotherapy (ICT) added to CRT.It showed improvement in recurrence free survival and overall survival.More importantly 96.7% of the experimental arm completed the treatment protocol. This was further confirmed by an updated network of meta analysis by Bongiovanni et al.Again the question of "when" is still valid.Our proposal is to compare tolerable regimen in induction versus adjuvant settings.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting Metabolic Vulnerabilities in Epstein-Barr Virus-Driven Proliferative Diseases.
    Leung NYT, Wang LW. · · 2023 · cited 4× · PMID 37444521 · DOI 10.3390/cancers15133412
  2. Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Induction Chemotherapy or Adjuvant Chemotherapy in Patients With Stage II-IVA Nasopharyngeal Carcinoma: A Propensity Score Matching Analysis and Meta-Analysis.
    Yang J, Liang ZG, Jiang YT, Chen KH, et al · · 2021 · cited 3× · PMID 34926289 · DOI 10.3389/fonc.2021.778836

Verify or expand the search:

Other recruiting trials for Nasopharyngeal Carcinoma

Currently open trials in the same condition.

Other Kuwait Cancer Control Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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