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NCT05527470 · ClinicalTrials.gov record · last posted 2023-05-03

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

StatusRecruiting
PhasePhase 3
SponsorWei Jiang
Started2022-11-11
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 3, 2023 (before its estimated November 11, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.

Amendment record 2 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 2 times since 2022-09-01; most recent amendment 2023-04-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-04-30
Status change Not Yet RecruitingRecruitingv2
2022-10-31
Status change RecruitingNot Yet Recruitingv1
Trial Details
NCT Number NCT05527470
Lead Sponsor Wei Jiang
Collaborators: Wuzhou Red Cross Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Lingshan people's Hospital, Laibin People's Hospital, Nationalities Hospital of Guangxi Zhuang Autonomous Region
Conditions Nasopharyngeal Carcinoma
Enrollment 440 participants
Start Date 2022-11-11
Primary Completion 2025-11-11 (estimated)
Study Completion 2027-11-11 (estimated)
Updated on ClinicalTrials.gov 2023-05-03