Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT01596868
Brief Summary:
The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC). The effectiveness, side effects and quality of life will be evaluated according to Standard WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H\&N35 questionnaire.
Detailed Description:
Nasopharyngeal carcinoma has an unique geographic distribution, and has different pathological types, natural history, treatment modalities in endemic and non-endemic regions. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. Chemoradiotherapy is the main therapy choice for the locoregionally advanced nasopharyngeal carcinoma. However,the optimal chemoradiotherapy regimen has not been determined. Many new drugs including docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The investigators designed the present study with induction chemotherapy follow by CCRT for locoregionally advanced NPC in non-endemic Northwest China, comparing induction chemotherapy regime of TP and GP. The primary objectives were overall response rate (ORR), acute toxicity, tolerance; second objective were overall survival (OS), progression free survival (PFS), rate of distant metastases,late adverse events and quality of life.
Study:
NCT01596868
Study Brief:
Protocol Section:
NCT01596868