Back to resultsA Study of Tongue Conservation Surgery for Oral Tongue Cancer
Primary Purpose
Tongue Cancer, Chemotherapy Effect, Surgery
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Induction chemotherapy
Tongue conservation surgery
postoperative CCRT
Sponsored by
About this trial
This is an interventional treatment trial for Tongue Cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Induction chemotherapy
Arm Description
Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
Outcomes
Primary Outcome Measures
Objective response rate
Response to induction chemotherapy
Secondary Outcome Measures
Tongue conservation surgery feasibility rates
Feasibility of tongue conservation surgery
Pathological response of induction chemotherapy
Pathological evaluation of rediual tumor status
Longitudinal quality of life (QOL)
Evaluation of QOL with the EORTC-C30 and HN35 QOL questionnaires
Oncologic results
Disease specific survival
Full Information
NCT ID
NCT03161548
First Posted
May 17, 2017
Last Updated
May 24, 2017
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03161548
Brief Title
A Study of Tongue Conservation Surgery for Oral Tongue Cancer
Official Title
A Phase II Study of Tongue Conservation Surgery for Advanced Oral Tongue Cancer: Induction Chemotherapy, Followed by Tongue Conservation Surgery and Postoperative Chemoradoitherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Diffiult patient recruitment
Study Start Date
July 18, 2011 (Actual)
Primary Completion Date
January 27, 2016 (Actual)
Study Completion Date
January 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Cancer, Chemotherapy Effect, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction chemotherapy
Arm Type
Experimental
Arm Description
Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
Intervention Type
Drug
Intervention Name(s)
Induction chemotherapy
Intervention Description
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
Procedure
Intervention Name(s)
Tongue conservation surgery
Intervention Description
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
Radiation
Intervention Name(s)
postoperative CCRT
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate
Description
Response to induction chemotherapy
Time Frame
2 weeks after completion of the last cycle of induction chemotherapy
Secondary Outcome Measure Information:
Title
Tongue conservation surgery feasibility rates
Description
Feasibility of tongue conservation surgery
Time Frame
the date of surgery
Title
Pathological response of induction chemotherapy
Description
Pathological evaluation of rediual tumor status
Time Frame
2 weeks after surgery
Title
Longitudinal quality of life (QOL)
Description
Evaluation of QOL with the EORTC-C30 and HN35 QOL questionnaires
Time Frame
Date of recruitment, 2 weeks after ICT completion, 3 months after treatement copletion, 1 year after treatment completion
Title
Oncologic results
Description
Disease specific survival
Time Frame
5 years after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of Tongue Conservation Surgery for Oral Tongue Cancer
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