TPF+CCRT vs.CCRT+PF in High Risk Nasopharyngeal Carcinoma

Status Active, not recruiting

Clinical Trial Summary

To see the effect of induction chemotherapy（TPF） followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy (PF) in treating patients with high risk nasopharyngeal carcinoma (NPC).

Clinical Trial Description

Patients presented with non-keratinizing NPC and stage AnyTN2-3M0 and plasma EBV DNA≥1500copies/ml are randomly assigned to receive TPF(paclitaxel liposome+cisplatin+5-fluorouracil) induction chemotherapy plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy plus PF (cisplatin+5-fluorouracil) adjuvant chemotherapy (control arm). Patients in both arms receive intensity-modulated radiotherapy(IMRT), and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm receive paclitaxel liposome (135mg/m2 on day 1), cisplatin (25mg/m2 on day 1-3) and 5-fluorouracil (750mg/m2 civ 120h) every three weeks for three cycles before the radiotherapy. Patients in the control arm receive adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every four weeks for three cycles after the radiotherapy. The primary end point is progress-free survival (PFS). Secondary end points include overall survival(OS),locoregional failure-free survival(LRRFS), distant metastasis-free survival(DMFS), overall response rates after treatments and toxic effects(short-term and long-term). All efficacy analyses are conducted in the intention-to-treat population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03306121
Study type	Interventional
Source	Sun Yat-sen University
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	November 13, 2017
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05979961` - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma	Phase 3
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT05415098` - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas	Phase 1
Recruiting	`NCT06055816` - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT05547971` - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting	`NCT05020925` - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 1/Phase 2
Not yet recruiting	`NCT04548271` - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 2
Not yet recruiting	`NCT04547088` - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT02795169` - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Terminated	`NCT02569788` - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Terminated	`NCT02801487` - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Completed	`NCT02237924` - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT02044562` - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients	N/A
Terminated	`NCT01694576` - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation	Phase 2
Recruiting	`NCT01462903` - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors	Phase 1
Completed	`NCT01271439` - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma	Phase 2
Completed	`NCT00535795` - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA	Phase 3
Completed	`NCT00379262` - Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma	Phase 3
Completed	`NCT03398980` - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy	N/A
Completed	`NCT01309633` - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC)	Phase 2