Actively Recruiting
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy
Led by Sun Yat-sen University · Updated on 2024-06-25
138
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.
CONDITIONS
Official Title
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO II or III)
- Clinical stage II to IVa according to the 8th AJCC edition
- Male or female who are not pregnant
- No evidence of distant metastasis (M0)
- Age between 18 and 65 years
- White blood cell count >= 4 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L
- Normal liver function tests: ALT, AST < 1.5x upper limit of normal; ALP <= 2.5x upper limit of normal; bilirubin <= upper limit of normal
- Normal renal function: creatinine clearance >= 60 ml/min or creatinine < 1.5x upper limit of normal
- Eastern Cooperative Oncology Group (ECOG) performance status <= 1
- Informed consent provided
- Receiving induction chemotherapy plus concurrent chemoradiotherapy, or concurrent chemoradiotherapy, or radiotherapy alone
You will not qualify if you...
- Age under 18 or over 65 years
- Clinical stage I or IVb according to the 8th AJCC edition
- Tumor recurrence or distant metastasis
- Prior malignancy except treated basal or squamous cell skin cancer, or in situ cervical cancer
- History of previous radiotherapy except for skin cancers outside treatment volume
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
- Pregnancy or lactation
- Any severe intercurrent disease posing unacceptable risk or affecting trial compliance, such as unstable cardiac disease, acute exacerbation of chronic respiratory illness requiring hospital admission, renal disease, chronic hepatitis, poorly controlled diabetes, or mental 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
Q
Qiu Yan Chen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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