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RECRUITING
NCT05527470
PHASE3

Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Sponsor: Wei Jiang

View on ClinicalTrials.gov

Summary

In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.

Official title: A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2022-11-11

Completion Date

2027-11-11

Last Updated

2023-05-03

Healthy Volunteers

No

Interventions

DRUG

Gemcitabine,Cisplatin

Induction chemotherapy: Patients receive 1000 mg/m2 gemcitabine intravenously on day 1and day 8, 80mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

RADIATION

Intensity-modulated radiation therapy (IMRT)

IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were \> 66 Gy to the primary tumor and \> 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.

DRUG

Cisplatin

Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

Locations (2)

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China