Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: standard chemoradiotherapy; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03403829

2017-NPC001

Details and patient eligibility

About

Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Full description

We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AJCC/UICC 8th edition N3 nasopharyngeal carcinoma
• Pathology: WHO II/II
• No prior anti-tumor treatment
• Age 18-60
• KPS≥70
• Adequate blood supply
• Informed consent obtained

Exclusion criteria

• Pathology: WHO I
• Pregnant
• Combined with other malignant tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

maintenance arm

Experimental group

Description:

Gemcitabine maintenance treatment

Treatment:

Drug: Gemcitabine

Radiation: standard chemoradiotherapy

control arm

Sham Comparator group

Description:

observe and follow-up

Treatment:

Radiation: standard chemoradiotherapy