Status:
COMPLETED
Neoadjuvant Chemotherapy and Low-dose Radiotherapy Sequential Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Sichuan Cancer Hospital and Research Institute
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Nasopharyngeal carcinoma（NPC）is common malignant tumor in China. The incidence of NPC in most parts of the world and the country is less than 1/10 million, but the incidence rate in China's Guangdong,...
Detailed Description
Nasopharyngeal carcinoma（NPC）is common malignant tumor in China. The incidence of NPC in most parts of the world and the country is less than 1/10 million, but the incidence rate in China's Guangdong,...
Eligibility Criteria
Inclusion
- Voluntarily participate and sign the informed consent form of the study in writing
- Age 18-70 years old, regardless of gender
- Pathological biopsy confirmed nasopharyngeal squamous cell carcinoma
- Initial treatment
- There are lesions that can be measured according to RECIST standard
- KPS score ≥ 80
- Estimated survival ≥ 6 months
- The urine pregnancy test was negative (female), and contraceptive measures were taken from the test period to 3 months after the end of the test
- Sufficient hematopoietic function: WBC ≥ 4 × 109/L，Hb≥100g/L，PLT≥100 × 109/L
- Liver function: ALAT / ASAT \< 1.5 times of ULN, bilirubin \< 1.5 × ULN
- Renal function: serum creatinine \< 1.5 × ULN
- No distant metastasis
- Lymph nodes meet one of them:node necrosis, extranodal invasion, or shortest diameter ≥3 cm
- The clinical stage was N2-3 (AJCC / UICC 8th Edition) locally advanced nasopharyngeal carcinoma
- According to the judgment of the researcher, the patient is considered to be able to comply with the protocol.
Exclusion
- There is evidence of distant metastasis
- The primary tumor or lymph node has been treated surgically (except biopsy)
- Patients with primary focus or lymph nodes who have received radiotherapy
- Those who have received epidermal growth factor targeted therapy
- The primary focus has received chemotherapy or immunotherapy
- Other malignant tumors (except non melanoma skin cancer or cervical carcinoma in situ)
- Subjects who have received other drug trials in recent 1 month
- Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period
- Have a serious history of allergy or special constitution
- A history of severe lung or heart disease or serious complications, such as uncontrollable hypertension and heart failure
- Refusal or inability to sign informed consent to participate in the trial
- Drug or alcohol addicts
- Having personality or mental illness, no civil capacity or limited civil capacity
- Creatinine clearance \< 30ml / min
- Active systemic infection
- At the same time, they received chronic systemic immunotherapy or hormone therapy other than this study.
Key Trial Info
Start Date :
March 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05292027
Start Date
March 26 2022
End Date
December 12 2024
Last Update
December 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041