Brief Title
De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title
De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
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.
Study Type
Interventional
Primary Outcome
DFS
Secondary Outcome
OS
Condition
Nasopharyngeal Carcinoma
Intervention
Toxicities reduced treatment
Study Arms / Comparison Groups
Toxicities reduced treatment
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
118
Start Date
November 1, 2019
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2022
Eligibility Criteria
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)
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Chaosu Hu, MD, +8613916162859, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04158518
Organization ID
2019-NPC001
Responsible Party
Sponsor-Investigator
Study Sponsor
Chaosu Hu
Study Sponsor
Chaosu Hu, MD, Principal Investigator, Fudan University Shanghai Cancer Centre
Verification Date
November 2019