Efficacy and safety of intravenous magnesium for the prevention of cisplatin-induced nephrotoxicity in patients with esophageal squamous cell carcinoma who received neoadjuvant chemotherapy: A phase II study. (MAGICIAN study (KDOG 2101))

Phase 2

Recruiting

• Conditions: esophageal squamous cell carcinoma; D000077277

• Registration Number: JPRN-jRCTs031210300
• Lead Sponsor: Watanabe Akinori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. A newly-diagnosed, histologically-confirmed esophageal squamous cell carcinoma
2. A resectable esophageal cancer with clinical stage I to III (UICC 8th edition)
3. Neoadjuvant chemotherapy regimen including high-dose cisplatin (> 70 mg/m2)
4. Age of 20 to 80 years old
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
6. Adequate organ function:
- Absolute neutrophil count > 2,000/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 10.0 g/dL
- Total bilirubin < 1.5 mg/dL
- AST < 100 U/L, ALT < 100 U/L
- Creatinine clearance > 50 mL/min
7. Serum magnesium level < 3.0 mg/dL
8. Written informed consent

Exclusion Criteria

1. A history of chemotherapy for cancer in another organ
2. Use of a reduced dose of cisplatin from the time of initial treatment
3. A history of hypersensitivity to magnesium products
4. Having myasthenia gravis
5. A history of therapy for heart block
6. Pregnant or breast feeding women, women of child-bearing potential
7. Patients who are judged inappropriate for entry into this study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Grade > 2 serum creatinine elevation according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome Measures

Name	Time	Method
1. Incidence and severity of nephrotoxicity based on creatinine clearance (Ccr) and estimated glomerular filtration rate (eGFR)<br>2. Changes in serum creatinine levels, Ccr and eGFR during neoadjuvant chemotherapy<br>3. Changes in urinary biomakers (N-acetyl-B-D-glucosaminidase (NAG), B2-microglobulin, and Liver-type fatty acid-binding protein (L-FABP)) during neoadjuvant chemotherapy<br>4. Change in serum magnesium level during neoadjuvant chemotherapy<br>5. Rates of chemotherapy dose delays, reductions, or discontinuations<br>6. Rates of changing chemotherapy regimen<br>7. Relative dose intensity<br>8. Evaluation of clinical and pathological responses according to the Response Evaluation Criteria in Solid Tumors (RECIST) and pathological criteria<br>9. Adverse event incidence based on CTCAE version 5.0<br>10. Incidence and severity of nephrotoxicity based on serum creatinine levels, Ccr, and eGFR for high-risk patients who have several risk factors for cisplatin-induced nephrotoxicity