Status:
UNKNOWN
Phase Ⅲ Trial of Adjuvant Chemotherapy in Patients With N2-3 Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To see the effect if a combination of concurrent chemoradiotherapy followed by different adjuvant chemotherapy in treating patients with N2-3 nasopharyngeal carcinoma(NPC).
Detailed Description
This phase Ⅲ trial is studying how well radiation therapy and chemotherapy work in treating patients with newly diagnosed N2-3 nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill ...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Original clinical staged as any T、N2-3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
- No evidence of distant metastasis (M0).
- Age 18-65 years old.
- ECOG Performance status less or equal to 1.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age \<18 or \>65 years.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03321539
Start Date
October 30 2017
End Date
December 31 2025
Last Update
May 22 2023
Active Locations (4)
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1
Department of Radiation Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
The Affiliated Hospital of Guizhou Medical University, Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550000
4
The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital
Changsha, Hunan, China, 410000