NCT02776163CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 30 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 12 May 2016
- Start date
- 1 Jun 2016
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Diseases
- Head and neck cancer
- NCT number
- NCT02776163
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 107
- From 1 Jun 2016 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- 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
Other illness
- Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
Other
- Evidence of distant metastasis
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
Who the study is looking for
- Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
- Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
- Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
- No evidence of distant metastases
- No synchronous or concurrent head and neck primary tumors
- Karnofsky score over 60
- Adequate organ function including the following:
- Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
- Platelets count \>= 100 \* 10\^9/l
- Hemoglobin \>= 10 g/dl
- AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
- Total bilirubin \<= 1.5 times institutional ULN
- Creatinine clearance \>= 50 ml/min
- Serum creatine \<= 1 times ULN
- Signed written informed consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Ninth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Long-Term Survival Outcomes of Concurrent Chemoradiotherapy for Postoperative High-Risk Salivary Gland Carcinomas.Cancer Med · 2026 · PMID 41878954
This page is information, not medical advice. Discuss any trial with your doctor.