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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00937612
• Other study ID #: CGHN-0801
• Status: Terminated
• Phase: N/A
• First received: July 9, 2009
• Last updated: February 6, 2017
• Start date: June 2008
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Radiation:
• Radiotherapy
postoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Keelung branch	Keelung
Taiwan	Chang Gung Memorial Hospital, Linkou Branch	Taoyuan
Taiwan	Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.		3 year