Clinical trial · Interventional
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
NCT02921984CI-TRIAL-00032148completedPhase 1ClinicalTrials.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)
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Salivary Gland Tumors | Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Intensity-modulated radiotherapy | Radiation | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Docetaxel arm
- description
- Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
- interventionNames
- Drug: Docetaxel
- Radiation: Intensity-modulated radiotherapy
- type
- EXPERIMENTAL
- label
- Pemetrexed arm
- description
- Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
- interventionNames
- Radiation: Intensity-modulated radiotherapy
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- Cisplatin arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade 2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin 3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual 4. No evidence of distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. Karnofsky score over 60 7. Adequate organ function including the following: 1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l 2. Platelets count \>= 100 \* 10\^9/l 3. Hemoglobin \>= 10 g/dl 4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) 5. Total bilirubin \<= 1.5 times institutional ULN 6. Creatinine clearance \>= 50 ml/min 7. Serum creatine \<= 1 times ULN 8. Signed written informed consent Exclusion Criteria: 1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
References
Publications (0)
Data not yet available
No reference posted for this study.