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Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk

This study has been terminated.
(Study group showed better 2-yr overall survival than historical control (89% vs 66%))
Sponsor:
Information provided by (Responsible Party):
Kang-Hsing Fan, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00937612
First received: July 9, 2009
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Head and Neck Neoplasms
Carcinoma, Squamous Cell
 Radiation: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended. [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2008
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: concurrent chemoradiation
patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation.
 Radiation: Radiotherapy
postoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin
Other Name: CGHN 3R trial

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    1. Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
    2. The tumor is located in the hard palate or the retromolar region.
    3. Poorly differentiated cell type.
    4. Tumor invasion to the nerve.
    5. Tumor invasion to lymphatic vessels.
    6. Tumor invasion to the small blood vessels.
    7. Tumor invasion to the bone.
    8. Tumor invasion to the skin.
    9. Depth of tumor invasion ≧ 10mm.
    10. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937612

Locations
Taiwan
Chang Gung Memorial Hospital, Keelung branch
Keelung, Taiwan, 222
Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch
Taoyuan, Taiwan, 333
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Kang-Hsing Fan, MD Chang Gung Memorial Hospital - LinKou Branch
  More Information

No publications provided

Responsible Party: Kang-Hsing Fan, Doctor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00937612     History of Changes
Other Study ID Numbers: CGHN-0801
Study First Received: July 9, 2009
Last Updated: February 9, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Head and Neck Neoplasms
Chemotherapy
Radiotherapy, Adjuvant
Surgery

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013