RATIONALE: The use of dentures and dental implants may help maintain chewing and speaking ability following surgery to remove tumors in the mouth. PURPOSE: Phase II trial to study the effectiveness of dentures and dental implants in maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer.

Condition	Treatment or Intervention	Phase
oral complications of cancer and cancer therapy stage III lip and oral cavity cancer stage II lip and oral cavity cancer Quality of Life stage I lip and oral cavity cancer	Procedure: supportive care  Procedure: surgery  Procedure: radiation therapy  Procedure: complications of therapy assessment/management  Behavior: supportive care/therapy  Procedure: quality-of-life assessment  Procedure: conventional surgery	Phase II

Further Study Details: 

OBJECTIVES: I. Determine whether conventional or implant supported dental prostheses and current surgical reconstructive procedures restore oral function and quality of life to pre-cancer surgery levels in patients with early oral cancer.

PROTOCOL OUTLINE: Patients complete a series of objective and subjective functional tests, questionnaires, and baseline examinations. Within 1-5 days, patients undergo the composite resection, including reconstructive surgery for the mandibulectomy group. Patients in the maxillectomy group receive an immediate maxillary surgical obturator. Approximately 6 weeks after ablative surgery, some patients receive radiotherapy for 5-7 weeks. Patients receive 2-4 implants at 12-16 weeks after completion of radiotherapy or 8-16 weeks after ablative surgery. Patients then receive conventional dentures at 4-22 weeks after implant surgery. Implants are exposed during 27-48 weeks after placement and abutments connected for fabricating dental prostheses. Approximately 8 weeks are needed to fabricate the implant supported prosthesis. Patients complete quality of life and other questionnaires prior to and at 8-21 weeks after surgery, 16 weeks after conventional denture insertion, and then 16 weeks after implant supported prosthesis insertion. Patients are followed every 6 months for at least 3 years.

PROJECTED ACCRUAL: A total of 62 patients (22 requiring maxillectomy and 40 requiring mandibulectomy) will be accrued for this study within 42 months.

Ages Eligible for Study:  35 Years   -   80 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of early oral cancer lesions requiring one of the following:

• Partial or total unilateral maxillectomy OR
• Partial lateral mandibulectomy with or without partial glossectomy

Edentulous or edentulous in the maxillary arch prior to or after ablative surgery (maxillectomy group)

Partial mandibulectomy leaving the condyles intact bilaterally (mandibulectomy group)

Must have sufficient bone in the selected implant sites to accommodate 2-4 implants of at least 10 mm in length

No temporomandibular dysfunction and/or functionally restrictive opening

No requirement for total glossectomy, reconstructive maxillary surgery, or maxillary sinus lift

No requirement for radiotherapy after mandibular reconstructive surgery

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: Not specified

Endocrine therapy: Not specified

Radiotherapy:

• See Disease Characteristics
• No prior or concurrent radiotherapy of greater than 5,500 cGY to potential implant site

Surgery: See Disease Characteristics

--Patient Characteristics--

Age: 35 to 80

Performance status: Not specified

Life expectancy: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Other:

• No oral discomfort that would preclude study
• No complications after ablative or reconstructive surgery that would preclude dental rehabilitation with implants

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Neal R. Garrett,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000066588; UCLA-HSPC-940205413; NCI-V00-1606; UCLA-DEN-1R01DE11255; UCLA-HSPC-940205411
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006341
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08