Clinical trial · Interventional
A Study of Tongue Conservation Surgery for Oral Tongue Cancer
A Phase II Study of Tongue Conservation Surgery for Advanced Oral Tongue Cancer: Induction Chemotherapy, Followed by Tongue Conservation Surgery and Postoperative Chemoradoitherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Diffiult patient recruitment
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Induction chemotherapy | Drug | — | UNRESOLVED |
| postoperative CCRT | Radiation | — | UNRESOLVED |
| Tongue conservation surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy
- description
- Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
- interventionNames
- Drug: Induction chemotherapy
- Procedure: Tongue conservation surgery
- Radiation: postoperative CCRT
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 2 weeks after completion of the last cycle of induction chemotherapy
- description
- Response to induction chemotherapy
Secondary outcomes (4)
- measure
- Tongue conservation surgery feasibility rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available