Actively Recruiting
Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)
Led by Sun Yat-sen University · Updated on 2022-03-03
220
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
Fujian Medical University Union Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to investigate whether the addition of metronomic capecitabine to the standard treatment can improve prognosis in locoregionally advanced head and neck squamous cell carcinoma.
CONDITIONS
Official Title
Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Performance status of ECOG grade 0 or 1
- Tumor stage III-IV (8th AJCC edition) with newly confirmed squamous cell carcinoma of oral cavity, oropharynx, larynx, or hypopharynx
- Completed one of the following treatments: radical surgery plus radiotherapy or concurrent chemoradiotherapy; neoadjuvant therapy plus radiotherapy or concurrent chemoradiotherapy; or concurrent chemoradiotherapy
- Postoperative radiotherapy started within 4 to 8 weeks after radical surgery
- Enrollment within 4 to 8 weeks after last radiation dose
- No clinical evidence of persistent locoregional disease or distant metastases before enrollment
- Adequate blood counts (neutrophils > 1.5 x 10^9/L, hemoglobin > 90 g/L, platelets > 100 x 10^9/L)
- Adequate liver function (ALT, AST ≤ 1.5 x ULN, bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN)
- Adequate kidney function (creatinine clearance ≥ 50 ml/min)
- Provided written informed consent after understanding study nature
You will not qualify if you...
- p16 positive tumor
- Known intolerance or allergy to capecitabine
- Conditions interfering with oral medication such as dysphagia, chronic diarrhea, or ileus
- Prior malignancy except treated basal or squamous cell skin cancer or in situ cervical cancer
- Pregnancy or lactation
- Prior surgery, chemotherapy, radiotherapy, or other anti-tumor treatments before standard therapy
- Surgery, biotherapy, or immunotherapy during radiotherapy
- Receiving or likely to receive other chemotherapy, biotherapy, or immunotherapy after radiotherapy
- Severe diseases that risk safety or compliance, including unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes, or emotional disturbance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Ying Sun, M.D.
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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