Clinical trial NCT03161548: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Tongue Cancer
Chemotherapy Effect
Surgery
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-05-22
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate
timeFrame: 2 weeks after completion of the last cycle of induction chemotherapy
Secondary outcomes:
measure: Tongue conservation surgery feasibility rates
timeFrame: the date of surgery
measure: Pathological response of induction chemotherapy
timeFrame: 2 weeks after surgery
measure: Longitudinal quality of life (QOL)
timeFrame: Date of recruitment, 2 weeks after ICT completion, 3 months after treatement copletion, 1 year after treatment completion
measure: Oncologic results
timeFrame: 5 years after treatment completion
Other outcomes:
Locations:
Study officials:
References: