Status:
UNKNOWN
Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (e...
Eligibility Criteria
Inclusion
- Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
- The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
- Initial treatment patients who have not received anti-tumor therapy;
- No history of other malignant tumors;
- Male or female, aged 18 to 70 years old;
- Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min;
- Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
- No serious heart, lung, liver, kidney and other important organ dysfunction;
- Karnofsky score ≥70 points;
- Sign the informed consent form;
- Able to follow research protocols and follow-up procedures.
Exclusion
- Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
- Find distant metastases before treatment;
- Women who are pregnant or breastfeeding;
- Disagree to sign the informed consent form;
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
- Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research);
- Known to be allergic to possible chemotherapy drugs;
- Patients with other malignant tumors;
- Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases;
- Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy;
- Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN;
- Any uncertain factors that affect patient safety or compliance.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT04766359
Start Date
March 1 2021
End Date
August 1 2025
Last Update
February 23 2021
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