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Study for the value of chemoradiotherapy after r0 operation of locally advanced esophageal carcinoma

Study for the value of chemoradiotherapy after r0 operation of locally advanced esophageal carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026229
Enrollment
Unknown
Registered
2019-09-27
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Esophageal Carcinoma

Interventions

experimental group:Surgery+Postoperative prophylactic chemoradiotherapy

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Postoperative pathology confirmed esophageal squamous cell carcinoma. 2. The postoperative pathological stage was pT1-2, N+, M0 or pT3-4, N0-3, M0. 3. There were no residual metastasis lymph node lesions in supraclavicular and abdominal cavity before entering the group. 4. There is a perfect staging examination before operation. 5. No matter what kind of operation, the number of lymph nodes should be more than 15, and there should be complete data of postoperative pathological stage. 6. Complete medical history and physical examination within six weeks of admission to this study. 7. Chest enhanced ct was performed within six weeks of entry into this study (pet/ct as an option). 8. EKG was performed in the first six weeks of random grouping in this study. 9. The ECOG score is 0-1. 10. Randomized distance operation time is less than 8 weeks. 11. More than 18 years old, less than 70 years old. 12. (1) Blood routine examination: absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelets >=100 x 10^9/L hemoglobin >= 9 g/dL; (2) Liver function: total bilirubin = 40 mL/min; 13. Both fertile women and men who take part in clinical trials need to take birth control. 14. Written informed consent form being signed. Agree to follow the study protocol and follow up procedures.

Exclusion criteria

Exclusion criteria: 1. Previous history of malignant tumors (except skin cancer, or in situ breast cancer, oral cancer, cervical cancer, etc., with an expected survival time of more than 2 years). 2. Multiple primary carcinoma of esophagus. 3. There are the following inclusion diseases: 1) Uncontrolled angina pectoris and heart failure, with a history of hospitalization in recent 3 months; 2) There was a history of myocardial infarction in recent 6 months; 3)In the presence of acute bacterial or fungal infections requiring antibiotic treatment; 4)If there is a chronic obstructive pulmonary disease attack or other pulmonary disease that needs to be hospitalized; 5) There are drug abuse and other adverse drug addiction and aids disease or virus carriers; 6) Have uncontrollable seizures or lose insight as a result of mental illness. 4. Women or men with fertility who do not intend to receive contraceptive treatment and treatment. 5. Local recurrence or distant metastasis was found before grouping.

Design outcomes

Primary

MeasureTime frame
Disease-Free Survival Time (DFS);Overall Survival Time (OS);

Secondary

MeasureTime frame
Side effects of treatment;

Countries

China

Contacts

Public ContactJin Gao

Anhui Provincial Cancer Hospital

gj11667@126.com+86 15395005376

Outcome results

None listed

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