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A prospective, randomized, phase II clinical study comparing Concurrent chemoradiotherapy with chemotherapy alone in patients with stage IV oligometastatic esophageal squamous cell carcinoma

A prospective, randomized, phase II clinical study comparing Concurrent chemoradiotherapy with chemotherapy alone in patients with stage IV oligometastatic esophageal squamous cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014386
Enrollment
Unknown
Registered
2018-01-10
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-15

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

Conditions

Stage ? oligometastatic esophageal squamous cell carcinoma

Interventions

A:chemoradiotherapy

Sponsors

Cancer Hospital of Sichuan province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. voluntary and signed written informed consent; 2. aged 18 to 75 years, sex not limited; 3. pathology or cytology in the diagnosis of esophageal squamous cell carcinoma; 4. clinic stage IV (distant metastases number = 5distant organ metastases number = 3); 5. NO previous treatment(who had not previously been treated by radiotherapy,chemotherapy or molecular targeted therapy); 6. primary tumor can be measured; 7. Karnofsky score >70; 8. survival is expected to exceed 3 months; 9. reproductive age women should ensure that before entering the study period contraception; 10. HB =100 g/L, WBC =4 ×10^9/L, platelet = 100 ×10^9/L; 11. liver function: the upper limit of normal value of ALT, AST 50%, DLCO (lung dispersion function) the percentage of measured value of estimated value >80%; 14. patients have good compliance to treatment and follow-up of acceptance.

Exclusion criteria

Exclusion criteria: 1. Do not meet the inclusion criteria for patients with pathologic type,stage and survival condition; 2. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas); 3. Other malignancies but exception of curative skin cancer(non-melanoma), cervical carcinoma in situ , bladder epithelial cancer in situ or malignant disease curatively more than 5 years; 4. Original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 5. There is serious allergic or idiosyncratic; 6. Refused or not signed the informed consent to participate in trials; 7. Patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. The researchers do not think participating in the study.

Design outcomes

Primary

MeasureTime frame
tumor size;

Countries

China

Contacts

Public ContactLi Tao
litaoxmf@126.com+86 18908178818

Outcome results

None listed

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