GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China

Phase 2

Completed

• Conditions: Nasopharyngeal Squamous Cell Carcinoma; Toxicity Due to Radiotherapy
• Interventions: Drug: gemcitabine and cisplatin; Drug: docetaxel and cisplatin

• Registration Number: NCT01596868
• Lead Sponsor: Air Force Military Medical University, China

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Histologically proven WHO II~III native NPC in northwest region of China;
• 18 Years to 70 Years;
• stages III-IVb according to AJCC stage classification(7th edition), no previous chemotherapy and radiotherapy;
• 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);
• Ability to comply with trial requirements.

Exclusion Criteria

• Evidence of metastases by clinical or radiographic examinations;
• History of malignancy;
• Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.;
• Patients with uncontrolled intercurrent disease;
• Patients with currently active malignancy;
• Pregnant or lactating women patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine and Cisplatin	gemcitabine and cisplatin	Drug: gemcitabine and cisplatin The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT..
docetaxel and cisplatin	docetaxel and cisplatin	Drug: Docetaxel and cisplatin TP regimen consists of docetaxel at a dose of 75 mg/m2/day on day 1, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR)	3-year

Secondary Outcome Measures

Name	Time	Method
Overall survival	3-year	Overall survival is calculated from randomization to death from any cause.
Locoregional failure-free survival	3-year	the date of randomization to the first local failure
Distant failure-free survival	3-year	from randomization to the first remote failure
Number of Participants with Adverse Events	3-year
Quality of life	3-year
Acute adverse reaction	3-year

Trial Locations

Locations (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military; 🇨🇳 Xi'an, Shanxi, China