De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04158518
• Other study ID #: 2019-NPC001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: Fudan University
• Contact: Youqi Yang, MD
• Phone: +8613916162859
• Email: yangyq[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Toxicities reduced treatment
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are = 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.
• Conventional treatment
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.

Locations

Country	Name	City	State
China	Fudan Universtiy Shanghai Cancer Centre	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chaosu Hu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	Disease Free Survival	3 year
Secondary	OS	Overall Survival	3 year