NCT06688175

IMRT Combined With Lobaplatin-based CCRT in Nasopharyngeal Carcinoma

Intensity-modulated Radiotherapy Combined With Lobaplatin-based Concurrent Chemotherapy in the Treatment of Elderly Patients With Nasopharyngeal Carcinoma

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter, single-arm, open-label phase II clinical study aimed to investigate the efficacy and safety of intensity-modulated radiotherapy combined with lobaplatin-based concurrent chemotherapy in the treatment of elderly patients with nasopharyngeal carcinoma

Detailed description

Lobaplatin, as a third-generation platinum-based chemotherapeutic agent, demonstrates equivalent therapeutic efficacy to cisplatin but significantly lower toxicity. Preliminary clinical trials have confirmed that lobaplatin shows substantial effectiveness in treating various cancers including breast cancer, esophageal cancer, colorectal cancer, and cervical cancer. Importantly, lobaplatin does not exhibit cross-resistance with cisplatin or carboplatin, indicating a promising application prospect. Currently, lobaplatin has demonstrated clear efficacy in non-elderly nasopharyngeal carcinoma (NPC) chemotherapy. Guo Xiang et al. have confirmed that for non-elderly NPC patients, induction chemotherapy with lobaplatin followed by concurrent chemoradiotherapy may be a treatment option for locally advanced NPC. However, there is very limited research reporting on the use of lobaplatin in elderly NPC patients. Based on the above theoretical considerations and our research results, lobaplatin shows good safety and reliable efficacy in treating elderly NPC, with minimal gastrointestinal reactions and low incidence of renal, neurotoxic, and ototoxic effects. This approach significantly enhances the quality of life for locally advanced elderly NPC patients. Therefore, the efficacy and safety of lobaplatin in concurrent chemotherapy for elderly NPC deserve further investigation. This study aims to evaluate the recent efficacy, safety, and toxic side effects of lobaplatin combined with intensity-modulated radiotherapy in the treatment of elderly NPC. Designed as a multicenter, open-label, prospective study, it aims to verify whether lobaplatin is an effective concurrent chemotherapeutic agent for elderly NPC, while further improving the quality of life for these patients under guarantees of therapeutic efficacy.

Conditions

• Nasopharyngeal Neoplasms
• Elderly
• Chemotherapy

Interventions

Type	Name	Description
DRUG	IMRT combined with lobaplatin-based concurrent chemotherapy	IMRT combined with two cycles of lobaplatin-based concurrent chemotherapy

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-11-14
• Last updated: 2025-08-07

Locations

1 site across 1 country: China