search
Back to results

Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cisplatin
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, radiation therapy, chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
  • Stage II disease (T1-2; N1; M0)
  • 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.
  • 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 UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival, and distant metastases free survival

Full Information

First Posted
January 2, 2009
Last Updated
January 5, 2009
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT00817258
Brief Title
Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
Official Title
Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (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 overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy. Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen
Detailed Description
Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been prospectively studied. In the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage II (T1-2N1) 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, radiation therapy, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin 40mg/m2,weekly
Intervention Type
Radiation
Intervention Name(s)
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Intervention Description
3D-CRT or IMRT
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 and 5 years
Secondary Outcome Measure Information:
Title
disease-free survival, and distant metastases 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: Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. Stage II disease (T1-2; N1; M0) 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. 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
Lin Kong, MD
Phone
8621-64175590
Ext
3900
Email
konglinj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Kong, MD
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, MD
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
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yuan
Phone
8621-64175590
Ext
6511
Email
skelly_sh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

We'll reach out to this number within 24 hrs