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Clinical study of raltitrexed and cisplatin combined intensity modulated conformal radiotherapy for locally advanced esophageal cancer

Clinical study of raltitrexed and cisplatin combined intensity modulated conformal radiotherapy for locally advanced esophageal cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016319
Enrollment
Unknown
Registered
2018-05-25
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

Esophageal cancer

Interventions

test group:Cisplatin + raltitrexet combined with intensity modulated conformal radiation therapy
control group:Cisplatin+5-FU Combined with Intensity Conformal Radiation Therapy

Sponsors

The first hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed esophageal squamous cell carcinoma (including high grade squamous intraepithelial neoplasia), clinical stage II-III; 2. Aged 18-70 years old, male or female; 3. There are measurable lesions (RECIST version 1.1); 4. ECOG physical status is 0-1, and the expected survival time is = 6 months; 5. At least fluid diet; 6. Laboratory inspections meet the following requirements: WBC = 4.0×10^9/L, neutrophil count = 2.0×10^9/L, PLT = 100×10^9/L, HB = 100g/L (without blood transfusion); total bilirubin, ALT, AST = 1.5 times the upper limit of normal; serum creatinine = upper limit of normal value (creatinine clearance = 65mL/min); normal ECG; 7. Voluntarily sign a treatment consent form.

Exclusion criteria

Exclusion criteria: 1. Cannot complete the designated pretreatment assessor; 2. The biopsy results are nonsquamous or no biopsy results; 3. Chemotherapy and chest radiotherapy before the start of the trial; 4. The primary disease becomes multifocal esophageal cancer; 5. Fiberoptic bronchoscopy or upper gastrointestinal angiography confirmed that there were tracheoesophageal fistulas and esophageal perforation, and active esophageal hemorrhage; 6. known to have an allergic reaction to any treatment 7. Pregnancy (confirmed by urine/blood examination), breast-feeding women or women who have fertility but have not used contraceptive measures; 8. history of malignancy in other sites; 9. with uncontrolled diabetes, high blood pressure, and severe cardiovascular or pulmonary disease; 10. Attending or participating in other clinical trials within the first four weeks of enrollment.

Design outcomes

Primary

MeasureTime frame
blood routine examination;Liver and kidney function;Heart and lung function;Chest-enhanced CT;Upper and lower cervical collarbone ultrasound scan;

Countries

China

Contacts

Public ContactGuang Li

The first hospital of China Medical University

13804058616@163.com+86 13804058616

Outcome results

None listed

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