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A Study of Tongue Conservation Surgery for Oral Tongue Cancer

NCT03161548 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-05-30

No results posted yet for this study

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

Interventions

DRUG

Induction chemotherapy

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

PROCEDURE

Tongue conservation surgery

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.

RADIATION

postoperative CCRT

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

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-18
Primary Completion
2016-01-27
Completion
2017-01-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161548 on ClinicalTrials.gov