De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

Not Applicable

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Toxicities reduced treatment; Radiation: Conventional treatment

• Registration Number: NCT04158518
• Lead Sponsor: Chaosu Hu

Brief Summary

The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-01
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Histological diagnosis of nasopharyngeal carcinoma
• Stage III or IVA according to UICC/AJCC 8th staging system
• Age ≥18
• No prior anti-tumor treatment
• Karnofsky Performance Score (KPS)≥70
• Adequate blood supply
• Informed consent obtained

Exclusion Criteria

• Can not take contrast-MRI imaging
• Pregnant
• Combined with other malignant tumor (except basal cell carcinoma of skin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Toxicities reduced treatment	Toxicities reduced treatment	Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
Conventional treatment	Conventional treatment	Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).

Primary Outcome Measures

Name	Time	Method
DFS	3 year	Disease Free Survival

Secondary Outcome Measures

Name	Time	Method
OS	3 year	Overall Survival

Trial Locations

Locations (1)

Fudan Universtiy Shanghai Cancer Centre; 🇨🇳 Shanghai, China