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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Neoplasms Carcinoma, Squamous Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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concurrent chemoradiation

patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation.

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

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

Interventions

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Radiotherapy

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

Intervention Type RADIATION

Other Intervention Names

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CGHN 3R trial

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No