GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nasopharyngeal Squamous Cell Carcinoma Toxicity Due to Radiotherapy	Drug: gemcitabine and cisplatin Drug: docetaxel and cisplatin	Phase 2

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

Resource links provided by NLM:

Drug Information available for: Cisplatin Gemcitabine Docetaxel Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:

overall response rate (ORR) [ Time Frame: 3-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Overall survival is calculated from randomization to death from any cause.
Locoregional failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
the date of randomization to the first local failure
Distant failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
from randomization to the first remote failure
Number of Participants with Adverse Events [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
Acute adverse reaction [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2012
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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..	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. Other Name: GP
Active Comparator: 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.	Drug: 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. Other Name: TP

Arms

Assigned Interventions

Active Comparator: 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..

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.

Other Name: GP

Active Comparator: 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.

Drug: 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.

Other Name: TP

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.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596868

Contacts

Contact: Mei Shi, PD

86-29-84775425

Shimei82@gmail.com

Locations

China, Shanxi
Department of Radiation Oncology, Xijing Hospital, Fourth Military	Recruiting
Xi'an, Shanxi, China, 710032
Contact: Mei Shi, MD 86-29-84775425 Shimei82@gmail.com

Sponsors and Collaborators

Fourth Military Medical University

Investigators

Principal Investigator:

Mei Shi, MD

department of radiation oncology

More Information

No publications provided

Responsible Party:	Mei Shi, Director and Professor of Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University, Fourth Military Medical University
ClinicalTrials.gov Identifier:	NCT01596868 History of Changes
Other Study ID Numbers:	Mshi
Study First Received:	May 7, 2012
Last Updated:	May 9, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:

Advanced Nasopharyngeal Carcinoma
treatment
Northwest China

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

Gemcitabine
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on June 17, 2013