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

Primary Purpose

Nasopharyngeal Squamous Cell Carcinoma, Toxicity Due to Radiotherapy

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gemcitabine and cisplatin
docetaxel and cisplatin
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Squamous Cell Carcinoma focused on measuring Advanced Nasopharyngeal Carcinoma, treatment, Northwest China

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Radiation Oncology, Xijing Hospital, Fourth Military

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gemcitabine and Cisplatin

docetaxel and cisplatin

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

overall response rate (ORR)

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2012
Last Updated
October 29, 2013
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01596868
Brief Title
GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Squamous Cell Carcinoma, Toxicity Due to Radiotherapy
Keywords
Advanced Nasopharyngeal Carcinoma, treatment, Northwest China

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine and Cisplatin
Arm Type
Active Comparator
Arm Description
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..
Arm Title
docetaxel and cisplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine and cisplatin
Other Intervention Name(s)
GP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Other Intervention Name(s)
TP
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall response rate (ORR)
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is calculated from randomization to death from any cause.
Time Frame
3-year
Title
Locoregional failure-free survival
Description
the date of randomization to the first local failure
Time Frame
3-year
Title
Distant failure-free survival
Description
from randomization to the first remote failure
Time Frame
3-year
Title
Number of Participants with Adverse Events
Time Frame
3-year
Title
Quality of life
Time Frame
3-year
Title
Acute adverse reaction
Time Frame
3-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
Organizational Affiliation
department of radiation oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Xijing Hospital, Fourth Military
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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