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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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
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.
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
Objective response rate
Response to induction chemotherapy
Time frame: 2 weeks after completion of the last cycle of induction chemotherapy
Tongue conservation surgery feasibility rates
Feasibility of tongue conservation surgery
Time frame: the date of surgery
Pathological response of induction chemotherapy
Pathological evaluation of rediual tumor status
Time frame: 2 weeks after surgery
Longitudinal quality of life (QOL)
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
Oncologic results
Disease specific survival
Time frame: 5 years after treatment completion
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