Prospective study of the surgical treatment of recurrent oral cavity carcinoma

Not Applicable

Recruiting

• Conditions: C00-C14; Malignant neoplasms of lip, oral cavity and pharynx

• Registration Number: DRKS00009255
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Written informed consent
2. Capacity to consent
3. Patients with histologically confirmed recurrence of squamous cell carcinoma of the oral cavity, which can be supplied on the basis of preoperative examination results of a curative surgical treatment.
4. General condition which enables a surgical treatment (ECOG=2; Karnofsky Index > 50)

Exclusion Criteria

1. Patients under 18 years
2. Poor general condition of the patient (ECOG=2, Karnofsky-Index < 50%)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to death

Secondary Outcome Measures

Name	Time	Method
1. Assessment of quality of life preoperatively, 6 months postoperatively and 12 months postoperatively based H & N35 and QLQ-C30 questionnaire.<br>2. Time to onset of recurrence histologically confirmed local recurrence (through regular follow-up examinations and control CT detected)<br>3. Time to occurrence of lymph node metastasis (through regular follow-up examinations and control CT detected)<br>4. Time to onset of distant metastasis (through regular follow-up examinations and control CT detected)<br>5. Tumor-related death