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Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC) (TPF for NPC)

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
docetaxel, cisplatin, fluorouracil
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
  • Stage Ⅲ, IVa and IVb disease
  • KPS >70
  • Age between 18-70
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
  • the primary tumor or involved lymph node must be more than 2CM in diameter.
  • No prior radiation treatment to the head and neck or any prior chemotherapy
  • Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion Criteria:

  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Prior radiotherapy to the head and neck region for any reason.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
  • Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
  • Pregnant women

Sites / Locations

  • Department of Radiation Oncology, Cancer Hospital, Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

distant metastases free survival , and disease-free survival

Full Information

First Posted
January 5, 2009
Last Updated
January 26, 2009
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00817583
Brief Title
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)
Acronym
TPF for NPC
Official Title
Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation. Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen. The third objective of this study is to evaluate who may benifit from this treatment regimen.
Detailed Description
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
Intervention Type
Drug
Intervention Name(s)
docetaxel, cisplatin, fluorouracil
Intervention Description
neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly
Intervention Type
Radiation
Intervention Name(s)
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 and 5 years
Secondary Outcome Measure Information:
Title
distant metastases free survival , and disease-free survival
Time Frame
3 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx. Stage Ⅲ, IVa and IVb disease KPS >70 Age between 18-70 Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min. the primary tumor or involved lymph node must be more than 2CM in diameter. No prior radiation treatment to the head and neck or any prior chemotherapy Patients with no prior malignancy (not include basal cell carcinoma of skin) Exclusion Criteria: Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. Prior radiotherapy to the head and neck region for any reason. Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ChaoSu HU, M.D.
Phone
86-21-64175590
Ext
6517
Email
hucsu62@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
XiaoShen WANG, M.D.
Phone
86-21-64175590
Ext
6516
Email
wangxiaoshen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoShen WANG, M.D.
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ChaoSu HU, M.D.
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ChunYing Shen, M.D.
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HongMei Ying, M.D.
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoshen Wang, M.D.
Phone
86-21-64175590
Ext
6516
Email
wangxiaoshen@gmail.com
First Name & Middle Initial & Last Name & Degree
TingTing Xu, M.D.
Phone
86-21-64175590
Ext
6511
Email
littlepuppyxtt@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

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