Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma
Status:
Recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
A prior phase III randomized trial showed considerable survival benefit from the combined
treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional
radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system)
nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known to
be superior to 2DCRT in local control, progression free survival and even overall survival,
it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010
International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging
system] patients can still obtain significant benefit from the additional concurrent
chemotherapy in the IMRT era.
The investigators' retrospective study (PMID:26528755 ) indicated that low risk
nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system)
patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy.
Therefore, the investigators perform this randomized controlled trial to address this
question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent
chemotherapy in stage II patients.
Phase:
Phase 3
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University Affiliated Tumor Hospital of Guangzhou Medical University The First Affiliated Hospital of Guangdong Pharmaceutical University The First Affiliated Hospital of Guangzhou Medical University