De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

Chaosu Hu

Status: Unknown

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Conventional treatment; Radiation: Toxicities reduced treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04158518

2019-NPC001

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Toxicities reduced treatment

Experimental group

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).

Treatment:

Radiation: Toxicities reduced treatment

Conventional treatment

Active Comparator group

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 concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).

Treatment:

Radiation: Conventional treatment