Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Fluorouracil

Cisplatin

Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred.

Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.

Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy.

Conventional chemotherapy

Maintenance chemotherapy 1

Maintenance chemotherapy 2

Lin Kong, MD

Jiyi Hu, MD

Yan Sun, MD

Jinshen Hong, MD

Qin Lin, MD

Xiaodong Zhu, MD

Heming Lu, MD

Guoqing Hu, MD

Xiaochang Gong, MD

Chaosu Hu, MD

Jiade J Lu, MD

Shengzi Wang, MD

Ping Li, MD

Boon Cher Goh, MD

Jin-Ching Lin, MD

The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.

This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m\^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m\^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.

Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Spots Global Cancer Trial Database for maintenance chemotherapy 1