Clinical trial · Interventional
Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas
Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial
NCT02776163CI-TRIAL-00079256completedPhase 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)
This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Intensity-modulated radiotherapy | Radiation | — | UNRESOLVED |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ACC
- description
- Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
- interventionNames
- Drug: Nedaplatin
- Drug: Docetaxel
- Radiation: Intensity-modulated radiotherapy
- type
- EXPERIMENTAL
- label
- Non-ACC
- description
- Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
- interventionNames
- Drug: Nedaplatin
- Drug: Docetaxel
- Radiation: Intensity-modulated radiotherapy
Primary outcomes (1)
- measure
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 (1)
- DERIVEDDou S, Wang X, Zhang L, Jiang W, Ye L, Wang Y, Li R, Zhu G. Long-Term Survival Outcomes of Concurrent Chemoradiotherapy for Postoperative High-Risk Salivary Gland Carcinomas. Cancer Med. 2026 Mar;15(3):e71722. doi: 10.1002/cam4.71722. PMID 41878954