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

NCT01596868 | Completed Phase 2 DMC

• 1 other identifier: Mshi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Squamous Cell Carcinoma; Toxicity Due to Radiotherapy

Keywords

Advanced Nasopharyngeal Carcinoma; treatment; Northwest China

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  3-year

Secondary Outcomes (6)

• Overall survival

  3-year

• Locoregional failure-free survival

  3-year

• Distant failure-free survival

  3-year

• Number of Participants with Adverse Events

  3-year

• Quality of life

  3-year

Study Arms (2)

Gemcitabine and Cisplatin

ACTIVE COMPARATOR

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

docetaxel and cisplatin

ACTIVE COMPARATOR

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

Interventions

gemcitabine and cisplatin DRUG

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.

Also known as: GP

Gemcitabine and Cisplatin

docetaxel and cisplatin DRUG

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.

Also known as: TP

docetaxel and cisplatin

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven WHO II\~III native NPC in northwest region of China;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Interventions

Gemcitabine; Cisplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Mei Shi, MD

  department of radiation oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor of Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 11, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

CN (1)