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

February 6, 2017 updated by: Kang-Hsing Fan, Chang Gung Memorial Hospital

A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Keelung, Taiwan, 222
        • Chang Gung Memorial Hospital, Keelung Branch
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou Branch
      • Taoyuan, Taiwan, 333
        • Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • CGHN 3R trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Kang-Hsing Fan, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGHN-0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Neoplasms

Clinical Trials on Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe