Clinical trial NCT00937612: Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
Official title: A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Neoplasms
Carcinoma, Squamous Cell
Keywords: Head and Neck Neoplasms
Chemotherapy
Radiotherapy, Adjuvant
Surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung branch
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou Branch
city: Taoyuan
country: Taiwan
facility: Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Kang-Hsing Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: