Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma

• Status: Completed
• Trial end date: 2020-12-20
• Target enrollment: 0
• Participant gender: All

Summary

The present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin; Fluorouracil; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically proven NPC diagnosis

• Elder than 18 years old are inclusive

• Recurrence or metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment

• Amenable to regular follow-up

• Subjects with at least one measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable).

• Performance status: 0-1(ECOG)

• WBC > 4.0X109/L, PLT > 100X109/L, with normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and bilirubin < 1.5 x upper limit of normal), with normal renal function (Creatinine < 1.5 x upper limit of normal)

• No chemotherapy or radical radiotherapy received within 6 months prior to enrollment

• Life expectancy over twelve weeks

• Signed and dated informed consent before the start of specific protocol procedures

• Ability to comply with trial requirements.

Exclusion Criteria:

• Patient suitable for local treatment (eg. radiotherapy)

• Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

• Patient with central nervous system metastasis

• Patient life threatening medical condition

• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.

• Performance status ≥ 2

• With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTC] grade ≥ 2)

• Serious concurrent illness

• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors[Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.

• Patient refusing participation