Epirubicin in patients with advanced or recurrent adenoid cystic carcinoma of the head and neck: a phase II study of the EORTC Head and Neck Cancer Cooperative Group.
J B Vermorken, J Verweij, P H de Mulder...
https://pubmed.ncbi.nlm.nih.gov/8280659Actively Recruiting
Phase 2
Age: 18Years - 70Years
All Genders
ID07320508
A Prospective, Multicenter Study of Transarterial Epirubicin Chemotherapy in the Treatment of Sinonasal Adenoid Cystic Carcinoma
Led by Eye & ENT Hospital of Fudan University · Updated on 2026-05-12
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment approach for patients with locally advanced sinonasal adenoid cystic carcinoma (SNACC), a rare cancer known for invading nerves and the skull base. The study aims to test a precise treatment strategy that adapts to how the tumor responds to initial chemotherapy. This prospective, multicenter trial seeks to evaluate the safety and effectiveness of this response-adapted approach and whether it can improve patient outcomes. All participants will receive three cycles of transarterial Epirubicin chemotherapy, which delivers high doses of the drug directly to the tumor every four weeks. About 4 to 6 weeks after the third cycle, MRI scans will assess tumor response. Based on imaging results, patients with incomplete tumor disappearance will undergo skull base surgery followed by radiotherapy, while those with complete tumor disappearance will receive precise radiotherapy alone, avoiding major surgery. During the study, participants will have regular MRI scans to monitor tumor response and safety assessments including laboratory tests and heart function evaluations. Researchers will measure the objective response rate after chemotherapy, progression-free survival over two years, and treatment-related side effects. Follow-up will continue for up to five years to assess overall survival and explore biomarkers linked to treatment response. The total participation involves initial chemotherapy, imaging, possible surgery or radiotherapy, and extended monitoring.
CONDITIONS
Brief Title
Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Histologically confirmed diagnosis of sinonasal adenoid cystic carcinoma (ACC)
- Tumor stage T3 or T4 according to AJCC 8th edition
- Participants with lymph node metastasis must be suitable for surgical dissection
- Participants with distant metastasis must have stable disease
- Ability to provide at least 0.5 cm³ of fresh tumor tissue for research
- ECOG performance status score between 0 and 2
- Voluntary participation with written informed consent and ability to comply with treatment and follow-up
You will not qualify if you...
- Previous treatment with Epirubicin or any anthracycline-based chemotherapy
- Prior radiotherapy to the head and neck region
- Use of chemotherapy, targeted therapy, or immunotherapy within 4 weeks before enrollment
- Participation in another interventional drug clinical trial
- Inadequate liver, kidney, or bone marrow function
- Allergy to anthracyclines or presence of Grade 2 or higher peripheral neuropathy
- Uncontrolled nausea, vomiting, or chronic gastrointestinal diseases
- Severe uncontrolled acute infection or major organ dysfunction
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 12 weeks
Participants receive three cycles of transarterial Epirubicin chemoinfusion, each cycle given every 4 weeks, as a neoadjuvant treatment.
3 visits for chemoinfusion, one every 4 weeks
Diagnostic Evaluation
Duration - 4 to 6 weeks
Participants undergo imaging assessment via MRI to evaluate tumor response after completion of chemotherapy.
1 visit for MRI assessment
Local Therapy
Duration - Variable duration depending on local therapy
Based on tumor response, participants either undergo skull base surgery followed by adjuvant radiotherapy or receive definitive radiotherapy alone.
Multiple visits depending on surgery and radiotherapy schedule
Follow-up
Duration - Up to 5 years
Participants are monitored for safety and long-term outcomes including progression-free and overall survival after local therapy.
Regular follow-up visits as per study schedule
Trial Site Locations
Total: 1 location
1
Eye and ENT Hospital, Fudan University
Shanghai, Xuhui Strict, China, 200031
Actively Recruiting
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Research Team
Q
Quan Liu, M.D.
W
Wanpeng Li, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Practical guideline for recurrent or metastatic adenoid cystic carcinoma.
Jiawei Zhou, Zhen Yu, Shuhang Wang...
https://pubmed.ncbi.nlm.nih.gov/40979299Distinct microscopic features of perineural invasion in adenoid cystic carcinoma of the head and neck.
Afshin Teymoortash, Lara Zieger, Stephan Hoch...
https://pubmed.ncbi.nlm.nih.gov/24033920Histopathological grading of adenoid cystic carcinoma of the head and neck: analysis of currently used grading systems and proposal for a simplified grading scheme.
Stijn van Weert, Isaäc van der Waal, Birgit I Witte...
https://pubmed.ncbi.nlm.nih.gov/25456010Sinonasal adenoid cystic carcinoma: the M. D. Anderson Cancer Center experience.
Allison D Lupinetti, Dianna B Roberts, Michelle D Williams...
https://pubmed.ncbi.nlm.nih.gov/17960615Proton therapy and/or helical tomotherapy for locally advanced sinonasal skull base adenoid cystic carcinoma: Focus on experience of the Institut Curie and review of literature.
Antoine Mavrikios, Farid Goudjil, Arnaud Beddok...
https://pubmed.ncbi.nlm.nih.gov/37097003Salivary gland carcinoma in Denmark 1990-2005: a national study of incidence, site and histology. Results of the Danish Head and Neck Cancer Group (DAHANCA).
Kristine Bjørndal, Annelise Krogdahl, Marianne Hamilton Therkildsen...
https://pubmed.ncbi.nlm.nih.gov/21612974Salivary gland adenoid cystic carcinoma: a review of chemotherapy and molecular therapies.
R L Dodd, N J Slevin
https://pubmed.ncbi.nlm.nih.gov/16757203