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Phase 2 clinical study for the precise 3DCRT/IMRT technology combined with S-1 in the treatment of elderly patients with locally advanced esophageal squamous cell carcinoma

Phase 2 clinical study for the precise 3DCRT/IMRT technology combined with S-1 in the treatment of elderly patients with locally advanced esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020876
Enrollment
Unknown
Registered
2019-01-21
Start date
2019-02-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Esophagus squamous cell carcinoma

Interventions

Group1:3DCRT/IMRT technology combined with S-1

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
75 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Patients volunteered to the research project and signed the Informed Consent; 2. All patients were aged =75 years, both male and female genders were included; 3. Patients with confirmed pathologic diagnoses of ESCC, had not received surgery, radiotherapy, chemotherapy or targeted therapy before this study. 4. According to TNM stages of the 6th AJCC/UICC in esophageal cancer, patients with staging for II to IVA local advanced ESCC were included. 5. No serious hematopoietic function, heart, lung, liver and kidney dysfunction and immunodeficiency. 6. Marrow and hepatorenal functions: leukocytes = 4000/µL, hemoglobin = 90 g/L (without blood transfusion), neutrophil = 2,100/µL and platelet = 100,000/µL, TBil (total bilirubin) < 1.5 times of the upper limit of normal range, AST /ALT=2.5 times of the upper limit of normal range, and creatinine (Cr) =1.5 times of the upper limit of normal range. 7. The loss of weight within 6 months before radiotherapy was less than 10%. 8. The expected survival period was longer than 3 months. 9. Eastern Cooperative Oncology Group (ECOG) score 1-2.

Exclusion criteria

Exclusion criteria: 1. Complete obstruction of the esophagus, deep ulcer or perforation or hematemesis in the esophagus; 2. Participated in other clinical trials at the same time; 3. Interstitial pneumonia or history of interstitial pneumonia; 4. Addicts, such as drug addiction, long-term alcohol abuse, and AIDS patients; 5. Uncontrollable seizures, or lost consciousness of mental illness; 6. History of severe allergies or a specific constitution; 7. Inappropriate to participate in the trial by the judgment of the investigator.

Design outcomes

Primary

MeasureTime frame
tumor size;??? survival rate;??? Local control rate;Progression Free Survival;Toxic reaction;

Countries

China

Contacts

Public ContactJinjun Ye

Jiangsu Cancer Hospital

jjye2004@163.com+86 13585175433

Outcome results

None listed

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