NCT05527470 Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
| NCT ID | NCT05527470 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Wei Jiang |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2022-11-11 |
| Primary Completion | 2025-11-11 |
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 440 participants in total. It began in 2022-11-11 with a primary completion date of 2025-11-11.
⚠ 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
In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.
Eligibility Criteria
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); 2. Tumor staged as III-IVb (according to the 8th AJCC edition); 3. No pregnant female; 4. Age between 18-65; 5. Normal complete blood count level (hemoglobin \>10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL); 6. Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase \< 2.5 times higher than upper limit); 7. Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min); 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. Without radiotherapy or chemotherapy; 10. Patients must give signed informed consent. Exclusion Criteria: 1. Disease progression in the process of the treatment; 2. The presence of uncontrolled life-threatening illness; 3. History of previous radiotherapy or chemotherapy; 4. Pregnancy or lactation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05527470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nasopharyngeal Carcinoma. 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 NCT05527470 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 440 participants.
Is NCT05527470 currently recruiting?
Yes, NCT05527470 is actively recruiting participants. Contact the research team at weijiang@glmc.edu.cn for enrollment information.
Where is the NCT05527470 trial being conducted?
This trial is being conducted at Guilin, China, Wuzhou, China.
Who is sponsoring the NCT05527470 clinical trial?
NCT05527470 is sponsored by Wei Jiang. The trial plans to enroll 440 participants.