NCT03919552 Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
| NCT ID | NCT03919552 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Cisplatin |
| Study Type | INTERVENTIONAL |
| Enrollment | 482 participants |
| Start Date | 2018-01-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 482 participants in total. It began in 2018-01-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.
Eligibility Criteria
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). * Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) \> 70. * 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 Criteria: * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Age ≥65 years or \<18 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.
Contact & Investigator
Jian Guan
STUDY CHAIR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT03919552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Cisplatin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03919552 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 482 participants.
Is NCT03919552 currently recruiting?
Yes, NCT03919552 is actively recruiting participants. Contact the research team at 51643930@qq.com for enrollment information.
Where is the NCT03919552 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT03919552 clinical trial?
NCT03919552 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jian Guan at Nanfang Hospital, Southern Medical University. The trial plans to enroll 482 participants.