A Study of Tongue Conservation Surgery for Oral Tongue Cancer

NCT03161548 | Terminated Phase 2

• 1 other identifier: 201009018MB
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tongue Cancer; Chemotherapy Effect; Surgery

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Response to induction chemotherapy

  2 weeks after completion of the last cycle of induction chemotherapy

Secondary Outcomes (4)

• Tongue conservation surgery feasibility rates

  the date of surgery

• Pathological response of induction chemotherapy

  2 weeks after surgery

• Longitudinal quality of life (QOL)

  Date of recruitment, 2 weeks after ICT completion, 3 months after treatement copletion, 1 year after treatment completion

• Oncologic results

  5 years after treatment completion

Study Arms (1)

Induction chemotherapy

EXPERIMENTAL

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

Drug: Induction chemotherapy; Procedure: Tongue conservation surgery; Radiation: postoperative CCRT

Interventions

Induction chemotherapy 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

Induction chemotherapy

Tongue conservation surgery 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.

Induction chemotherapy

postoperative CCRT 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

Induction chemotherapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Conditions

Tongue Neoplasms

Interventions

Induction Chemotherapy

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential doxcetaxel, cisplatin and tegafur/uracil plus leucovorin (DCU) induction chemotherapy, tongue conservation surgery and postoperative CCRT in patients with advanced oral tongue cancer.

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 22, 2017
• Study Start: July 18, 2011
• Primary Completion: January 27, 2016
• Study Completion: January 4, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share