Back to resultsPostoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
Primary Purpose
Head and Neck Neoplasms, Carcinoma, Squamous Cell
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Head and Neck Neoplasms, Chemotherapy, Radiotherapy, Adjuvant, Surgery
Eligibility Criteria
Inclusion Criteria:
Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
- Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
- The tumor is located in the hard palate or the retromolar region.
- Poorly differentiated cell type.
- Tumor invasion to the nerve.
- Tumor invasion to lymphatic vessels.
- Tumor invasion to the small blood vessels.
- Tumor invasion to the bone.
- Tumor invasion to the skin.
- Depth of tumor invasion ≧ 10mm.
- Occurred in single lymph node metastasis.
Exclusion Criteria:
- No or presence of adverse prognostic factor but less than 2.
- Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
- ECOG performance status > 2.
- Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
- Women during pregnancy.
Sites / Locations
- Chang Gung Memorial Hospital, Keelung branch
- Chang Gung Memorial Hospital, Linkou Branch
- Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
concurrent chemoradiation
Arm Description
patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation.
Outcomes
Primary Outcome Measures
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
Secondary Outcome Measures
Full Information
NCT ID
NCT00937612
First Posted
July 9, 2009
Last Updated
February 6, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00937612
Brief Title
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
Official Title
A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Study group showed better results. Poor Accrual.
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.
Detailed Description
Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Carcinoma, Squamous Cell
Keywords
Head and Neck Neoplasms, Chemotherapy, Radiotherapy, Adjuvant, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
concurrent chemoradiation
Arm Type
Experimental
Arm Description
patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
CGHN 3R trial
Intervention Description
postoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin
Primary Outcome Measure Information:
Title
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
Time Frame
3 year
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:
Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
The tumor is located in the hard palate or the retromolar region.
Poorly differentiated cell type.
Tumor invasion to the nerve.
Tumor invasion to lymphatic vessels.
Tumor invasion to the small blood vessels.
Tumor invasion to the bone.
Tumor invasion to the skin.
Depth of tumor invasion ≧ 10mm.
Occurred in single lymph node metastasis.
Exclusion Criteria:
No or presence of adverse prognostic factor but less than 2.
Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
ECOG performance status > 2.
Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
Women during pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang-Hsing Fan, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Keelung branch
City
Keelung
ZIP/Postal Code
222
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
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