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

Toxicity Due to Radiotherapy Clinical Trial

Official title:

A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596868
• Other study ID #: Mshi
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2012
• Last updated: October 29, 2013
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Nasopharyngeal Neoplasms
• Nasopharyngeal Squamous Cell Carcinoma
• Toxicity Due to Radiotherapy

Intervention

Drug:
• 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
Drug: Docetaxel and cisplatin The 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.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate (ORR)		3-year	No
Secondary	Overall survival	Overall survival is calculated from randomization to death from any cause.	3-year	No
Secondary	Locoregional failure-free survival	the date of randomization to the first local failure	3-year	No
Secondary	Distant failure-free survival	from randomization to the first remote failure	3-year	No
Secondary	Number of Participants with Adverse Events		3-year	Yes
Secondary	Quality of life		3-year	Yes
Secondary	Acute adverse reaction		3-year	Yes