Actively Recruiting
Reduced-target Resection After Induction Chemotherapy in Resectable Recurrent Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2023-05-26
424
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare efficacy of two different resection extension in patients with resectable recurrent nasopharyngeal carcinoma after induction chemotherapy. The main question it aims to answer is that whether tumor regress areas after induction chemotherapy required complete resection. Patients will be randomly assigned to receive reduced-target resection or full-target resection after induction chemotherapy. Researchers will compare these two groups to see if the efficacy of reduced-target resection is not inferior to full-target resection.
CONDITIONS
Official Title
Reduced-target Resection After Induction Chemotherapy in Resectable Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrence occurs more than 6 months after completing radiotherapy
- Histologically confirmed recurrent nasopharyngeal carcinoma
- Resectable recurrent tumors classified as T1, T2, or T3 according to AJCC 8th edition
- If tumor involves internal carotid artery less than 0.5 cm but not beyond external edge, internal carotid artery pretreatment is allowed
- At least partial tumor response after 3 cycles of platinum-based or GAP regimen induction chemotherapy with over 50% reduction in planning surgical tumor volume
- Provided written informed consent
You will not qualify if you...
- Karnofsky Performance Status below 70
- Severe medical disorder, important organ dysfunction, or substantial history of mental illness
- Tumor confined to roof or posterior wall of nasopharynx without expected benefit from reduced-target resection
- Unresectable recurrent regional lymph nodes involving prevertebral fascia, cervical vertebrae, or carotid artery
- Clinically diagnosed metastatic nasopharyngeal carcinoma
- Presence of other malignant tumors except cured skin basal cell carcinoma or cervical carcinoma in situ
- Systemic or local glucocorticoid therapy within 4 weeks before study treatment
- Long-term immunosuppressive treatment or immunosuppressive-dose glucocorticoid therapy
- Prior therapy with PD-1, PD-L1, or CTLA-4 agents
- Active autoimmune disease requiring systemic treatment, except certain skin diseases
- Known HIV infection, hepatitis B with high viral load, or hepatitis C infection
- Live vaccine received within 4 weeks before study treatment
- Pregnancy or breastfeeding
- Inability to complete regular follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
Y
Youping Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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