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A multicenter Randomized, parallel controlled trial for protective effect of calcium folinate in brain metastases of lung cancer receiving radiotherapy

A multicenter Randomized, parallel controlled trial for protective effect of calcium folinate in brain metastases of lung cancer receiving radiotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022735
Enrollment
Unknown
Registered
2019-04-23
Start date
2019-04-15
Completion date
Unknown
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Experimental group:From the 3 days before brain radiotherapy to the end of brain radiotherapy, combined with calcium folinate injection
Control group:without calcium folinate injection

Sponsors

the Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old male and female; 2. Pathologically confirmed as a malignant tumor of the lung, after the treatment of chemotherapy and targeted therapy, the brain PD was evaluated and confirmed by imaging; 3. The number of brain metastases is more than 3 or the diameter of a single metastase is greater than 5cm, or ventricular invasion, cerebellar metastasis, meningeal metastasis; 4. Expected survival time = 3 months; 5. The patient's general condition score is = 2 points according to the ECOG ( Eastern Cooperative Oncology Group) score; 6. The patient must meet all of the following conditions: white blood cell count at 4,000 to 10,000/mm3; neutrophil count = 2,000/mm3; platelet count = 100,000/mm3; hemoglobin = 11.0 g/dL; aspartate aminotransferase (AST) and glutamic acid Transaminase (ALT) = 1.5 times the upper limit of normal; total bilirubin = 24umol/L and serum creatinine = 85umol/L.

Exclusion criteria

Exclusion criteria: 1. Before the brain radiation treatment; 2. Bio-targeted therapy is underway; 3. For single-shot, maximum diameter less than 4cm brain metastases suitable for SRS; 4. Patients with a history of severe allergies or allergies; 5. The following serious diseases: uncontrollable infections, severe heart failure and myocardial infarction that have occurred in the past 6 months; 6. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Brain magnetic resonance;Electrocardiogram;white blood cell;platelet;Glutamic pyruvic transaminase;glutamic-oxalacetic transaminase;

Countries

China

Contacts

Public ContactZibin Liang

Department of thoracic oncology, the cancer center of the fifth affiliated hospital of Sun Yat-sen University

13926927919@139.com+86 13926927919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026