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

Phase 2
18 Years
70 Years
Not Enrolling
Head and Neck Neoplasms, Carcinoma, Squamous Cell

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.

Outcome Time Frame:

3 year

Safety Issue:


Principal Investigator

Kang-Hsing Fan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chang Gung Memorial Hospital - LinKou Branch


Taiwan: Department of Health

Study ID:




Start Date:

June 2008

Completion Date:

March 2014

Related Keywords:

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Chemotherapy
  • Radiotherapy, Adjuvant
  • Surgery
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms