A Study of Tongue Conservation Surgery for Oral Tongue Cancer

NCT ID: NCT03161548

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-18
• Study Completion Date: 2017-01-04

Brief Summary

This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential induction chemotherapy, tongue conservation surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral tongue cancer.

Detailed Description

Surgical resection remains the most important component of standard treatment for oral tongue cancer, but may lead to profound functional impacts not effectively compensated by reconstruction surgery. The volume of tongue resection remains one key factor for the post-treatment deterioration of the functional outcomes and quality of life in large oral tongue cancer. Primary chemoradiotherapy without surgical resection has not been accepted for oral tongue cancer because of the concerns about possible poorer response and sequelae. Breast conservation treatment, by the sequential use of induction chemotherapy (ICT), limited surgical resection and chemoradiotherapy, has become a standard treatment for human breast cancer of various stages. However, similar tongue conservation treatment for advanced oral tongue cancer has not been studied in trials. Based on these data, it will be reasonable, in locally advanced (> 3 cm) resectable oral tongue cancers, to test whether ICT followed by tongue conservation surgery and postoperative CCRT can safely enhance the possibility of tongue conservation with improved post-treatment functions.

Conditions

Tongue Cancer; Chemotherapy Effect; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction chemotherapy

Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.

Group Type: EXPERIMENTAL

Induction chemotherapy

Intervention Type: DRUG

All eligible subjects will receive ICT with DCU regimen every 21 days as follows:

Docetaxel 36 mg/m2 intravenous infusion over 1 hr, followed by Cisplatin 30 mg/m2 intravenous infusion over 1 hr, on day 1 and day 8, Oral tegafur/uracil 300 mg/m2/day plus leucovorin 90 mg/day on days 1 - 14

Tongue conservation surgery

Intervention Type: PROCEDURE

Surgical excision of residual oral tongue tumor will be performed in 3-4 weeks after the start of the last cycle of ICT. Neck dissection will also be done as indicated.

postoperative CCRT

Intervention Type: RADIATION

Post-op CCRT will be started 4-6 weeks after surgery, with regimen as follows:

Radiotherapy in 2 Gy once-daily fraction size, Monday to Friday, with dose up to 60 Gy (total of 30 fractions); Cisplatin 25 mg/m2 intravenously for 4 hours every week a cycle to total 6 cycles; Tegafur/uracil (UFUR) 200 mg po bid for whole course of radiotherapy

Interventions

Induction chemotherapy

All eligible subjects will receive ICT with DCU regimen every 21 days as follows:

Docetaxel 36 mg/m2 intravenous infusion over 1 hr, followed by Cisplatin 30 mg/m2 intravenous infusion over 1 hr, on day 1 and day 8, Oral tegafur/uracil 300 mg/m2/day plus leucovorin 90 mg/day on days 1 - 14

Intervention Type: DRUG

Tongue conservation surgery

Surgical excision of residual oral tongue tumor will be performed in 3-4 weeks after the start of the last cycle of ICT. Neck dissection will also be done as indicated.

Intervention Type: PROCEDURE

postoperative CCRT

Post-op CCRT will be started 4-6 weeks after surgery, with regimen as follows:

Radiotherapy in 2 Gy once-daily fraction size, Monday to Friday, with dose up to 60 Gy (total of 30 fractions); Cisplatin 25 mg/m2 intravenously for 4 hours every week a cycle to total 6 cycles; Tegafur/uracil (UFUR) 200 mg po bid for whole course of radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients with histological proof of squamous cell carcinoma of oral tongue
• b. cT2-4, N0-2,M0, by clinical or radiographic examinations
• Either mandibulotomy, mandibulectomy or flap reconstruction is required by standard surgical planning
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Between 20 and 70 years of age
• Adequate hematopoietic function as defined below:

Hemoglobin >= 10g/dl Absolute neutrophil count (ANC) >= 1,500/µL Platelets >= 100,000/µL

• Adequate organ function as defined below:

Total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine <= 1.5 x upper limit of normal Creatinine clearance > 50 ml/min

• Signed study-specific consent form prior to study entry

Exclusion Criteria

• Patients received gross oral tongue tumor resection before evaluation
• Primary subsites other than oral tongue
• Histologic diagnosis other than squamous cell carcinoma
• Patient with synchronous primary cancers (within 6 months)
• Clinical or radiographic findings as below:

T1 tumors Gross invasion to mandible, tonsil or >1/3 base of tongue N3 disease or distant metastasis (M1)

• Prior head and neck chemotherapy or radiotherapy
• Prior esophageal cancer history
• Active cardiac disease defined as: unstable angina, uncontrolled arrhythmia, myocardial infarction within 6 months.
• Severe chronic obstructive pulmonary disease (COPD) requiring ≥ 3 hospitalizations over the past year
• Mental status not fit for clinical trial.
• Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201009018MB

Identifier Type: -

Identifier Source: org_study_id