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

Cisplatin

Antimetabolites

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.

Inductive chemotherapy + concurrent cisplatin and IMRT

Inductive chemotherapy + IMRT

Janjun Li, M.D.

Lizhi Liu, M.D.

Jian-jun Li, MD

Jian-jun Li, M.D.

Li-zhi Liu, M.D.

yong Su, M.D.

Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.

The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.

Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC

Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma

Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.

Overall survival is calculated from randomization to death from any cause.

Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Sun Yat-sen University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC	NCT01854203	Nasopharyngeal ...	Inductive chemo... Inductive chemo...	18 Years - 65 Years	Sun Yat-sen University
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC	NCT01854203	Nasopharyngeal ...	Inductive chemo... Inductive chemo...	18 Years - 65 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for inductive chemotherapy + concurrent cisplatin and imrt