Clinical trial NCT06688175: IMRT Combined with Lobaplatin-based CCRT in Nasopharyngeal Carcinoma
Official title: Intensity-modulated Radiotherapy Combined with Lobaplatin-based Concurrent Chemotherapy in the Treatment of Elderly Patients with Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Elderly
Chemotherapy
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 3 months
measure: Overall survival (OS)
timeFrame: 3 years
measure: Locoregional relapse-free survival (LRFS)
timeFrame: 3 years
measure: Distant metastasis-free survival (DMFS)
timeFrame: 3 years
measure: Progression-free survival (PFS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: