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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025490

Enrollment

Unknown

Registered

2019-08-28

Start date

2019-02-01

Completion date

Unknown

Last updated

2019-09-02

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:3 days before brain radiotherapy, after the end of brain radiotherapy, use calcium leucovorin + Mannitol/dehydration therapy

Control group:Mannitol/dehydration therapy

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

Measure	Time frame
brain magnetic resonance;Electrocardiogram;white blood cell;platelet;Glutamic pyruvic transaminase;	—

Countries

China

Contacts

Public ContactZibin Liang

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

Liangzb@mail.sysu.edu.cn+86 13926927919

Outcome results

None listed

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