IMRT Combined With Lobaplatin-based CCRT in Nasopharyngeal Carcinoma

NCT06688175 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: 2022-KY062
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nasopharyngeal Neoplasms; Elderly; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  ORR encompasses both CR and PR.

  6 months

Secondary Outcomes (5)

• Safety

  3 months

• Overall survival (OS)

  3 years

• Locoregional relapse-free survival (LRFS)

  3 years

• Distant metastasis-free survival (DMFS)

  3 years

• Progression-free survival (PFS)

  3 years

Study Arms (1)

Experimental

EXPERIMENTAL

in the treatment of elderly patients with nasopharyngeal carcinoma

Drug: IMRT combined with lobaplatin-based concurrent chemotherapy

Interventions

IMRT combined with lobaplatin-based concurrent chemotherapy DRUG

IMRT combined with two cycles of lobaplatin-based concurrent chemotherapy

Experimental

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma;
• Stage II-IVa (UICC 8th edition);
• Acceptable induction chemotherapy and Tarceva targeted therapy;
• No history of other malignant tumors;
• Male or female, aged 65-80 years.
• Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 5 times ULN;
• Renal function: Creatinine clearance ≥ 60 ml/min or Creatinine ≤ 1.5 × ULN;
• Hematological tests: Absolute Neutrophil Count (ANC) ≥ 2 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, and Hemoglobin ≥ 9 g/dL;
• No severe dysfunction of vital organs such as heart and lung;
• PS score ≤ 2 points

You may not qualify if:

• Distant metastases detected before treatment;
• Refusal to sign the informed consent form;
• Patients who cannot comply with regular follow-up due to psychological, social, family, or geographical reasons;
• Simultaneously receiving other experimental treatments in clinical trials (during the treatment phase of clinical research);
• Severe, uncontrolled infections or medical conditions;
• Vital organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy and chemotherapy;
• Laboratory tests: Total bilirubin \> Upper Limit of Normal (ULN); AST and/or ALT \> 1.5 times ULN with alkaline phosphatase \> 2.5 times ULN;
• Factors affecting drug administration, distribution, metabolism, and excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.;
• Long-term use of immunosuppressants after organ transplantation;
• Patients with a history of other malignant tumors before enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)