Clinical trial · Interventional
Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study
NCT05008237CI-TRIAL-00053335unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cisplatin plus weekly docetaxel as first-line chemotherapy in metastatic salivary gland cancer patients : a multicenter phase II study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel plus Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin plus docetaxel
- description
- D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.
- interventionNames
- Drug: docetaxel plus Cisplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 30months
- description
- To evaluate the effectiveness of regimen. The overall response rate will be measured by RECIST v1.1.
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- The time until defineded by date of all-cause mortality from date of IP administration. Up to 30 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically-confirmed salivary gland cancer with one of the following histologic subtypes : mucoepidermoid, adenocarcinoma/ductal carcinoma or adenoid cystic carcinoma
* Only progressive disease in case of ACC
* Progressive disease is defined as one of the following occurring within 6 months of study entry (i) at least a 20% increase in radiologically or clinically measurable disease, (ii) appearance of new lesions or (iii) deterioration in clinical status
* stage IV or recurrent cancer which is incurable with surgery or radiotherapy
* age ≥ 20 years
* ECOG performance status 0-1 ⑥ At least one measurable tumor lesion according to RECIST 1.1
* Expected survival for approximately 12 weeks or longer
⑧ No prior systemic chemotherapy (Patients who received adjuvant chemotherapy or chemoradiotherapy completed more than 6 months before will be eligible)
* At least 4 weeks later after major surgery or radiotherapy ⑩ Organ function as evidence by the following; WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 10 g/dL (transfusion allowed), Platelet count ≥ 100,000 plts/mm3; Total bilirubin ≤ 1.5 ULN AST/ALT ≤ 2.5 ULN, (if liver metastases: AST, ALT ≤5.0 x ULN); Creatinine clearance 50 mL/min or serum creatinine ≤ 1.5 x UNL ⑪ Written informed consent
Exclusion Criteria:
* Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
* Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
* Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method) ④ Symptomatic CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed) ⑤ Patients with alcohol abuseReferences
Publications (0)
Data not yet available
No reference posted for this study.