A Study of Tongue Conservation Surgery for Oral Tongue Cancer

Phase 2

Terminated

• Conditions: Tongue Cancer; Surgery; Chemotherapy Effect
• Interventions: Drug: Induction chemotherapy; Procedure: Tongue conservation surgery; Radiation: postoperative CCRT

• Registration Number: NCT03161548
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2011-07-18
• Primary Completion: 2016-01-27
• Study Completion: 2017-01-04
• Status Verified: 2017-05
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective response rate	2 weeks after completion of the last cycle of induction chemotherapy	Response to induction chemotherapy

Secondary Outcome Measures

Name	Time	Method
Pathological response of induction chemotherapy	2 weeks after surgery	Pathological evaluation of rediual tumor status
Longitudinal quality of life (QOL)	Date of recruitment, 2 weeks after ICT completion, 3 months after treatement copletion, 1 year after treatment completion	Evaluation of QOL with the EORTC-C30 and HN35 QOL questionnaires
Oncologic results	5 years after treatment completion	Disease specific survival
Tongue conservation surgery feasibility rates	the date of surgery	Feasibility of tongue conservation surgery