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

NCT00937612 | Terminated DMC

• 1 other identifier: CGHN-0801
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Keywords

Head and Neck Neoplasms; Chemotherapy; Radiotherapy, Adjuvant; Surgery

Outcome Measures

Primary Outcomes (1)

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

  3 year

Study Arms (1)

concurrent chemoradiation

EXPERIMENTAL

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

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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

Also known as: CGHN 3R trial

concurrent chemoradiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
• The tumor is located in the hard palate or the retromolar region.
• Poorly differentiated cell type.
• Tumor invasion to the nerve.
• Tumor invasion to lymphatic vessels.
• Tumor invasion to the small blood vessels.
• Tumor invasion to the bone.
• Tumor invasion to the skin.
• Depth of tumor invasion ≧ 10mm.
• Occurred in single lymph node metastasis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (3)

Chang Gung Memorial Hospital, Keelung branch

Keelung, 222, Taiwan

Location

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, 333, Taiwan

Location

Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kang-Hsing Fan, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Prospective cohort

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2014
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

TW (3)