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

Chang Gung Medical Foundation

Status

Terminated

Conditions

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Treatments

Radiation: Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00937612

CGHN-0801

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.