NCT04061278

A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

Status unknown Phase 3 Last updated 12 May 2020

What this trial tests

Phase 3 trial testing 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy in Nasopharyngeal Carcinoma in 246 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
30 June 2022

31 December 2022

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	246
Start date	1 August 2019
Primary completion	30 June 2022
Estimated completion	31 December 2022
Sites	12 locations across China

Drugs / interventions tested

• 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy — full drug profile →
• 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy — full drug profile →

Conditions studied

• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
• Neoadjuvant Chemotherapy — all drugs for Neoadjuvant Chemotherapy →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 70, any sex, with Nasopharyngeal Carcinoma or Neoadjuvant Chemotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Induction Chemotherapy Plus Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy Alone in Locally Advanced Nasopharyngeal Carcinoma.
   Xu G, Wang Q, Wu X, Lv C, et al · · 2021 · cited 6× · PMID 33511908 · DOI 10.1177/1533033821990017