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Phase II clinical study for adjuvant IMRT combined with TP chemotherapy after R0 resection of thoracic esophageal squamous cell carcinoma

Phase II clinical study for adjuvant IMRT combined with TP chemotherapy after R0 resection of thoracic esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022689
Enrollment
Unknown
Registered
2019-04-22
Start date
2019-04-25
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

esophageal squamous cell carcinoma

Interventions

single arm:IMRT combined with TP scheme concurrent chemotherapy

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
38 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) voluntarily participating in and signing the letter of informed consent in writing; 2) aged 18 to 70 years, male or female; 3) the postoperative pathology proved to be the primary esophageal squamous cell carcinoma; 4) the physical status score was ECOG 0~2; 5) packet distance operation time less than March; 6) the number of lymph node was 12; 7) postoperative pathology was postoperative pathology: T3 - 4 or lymph node positive, M0; 8) no radiotherapy, chemotherapy or target therapy before and after operation; 9) a male or female with fertility ability is willing to take contraceptive measures in the experiment; 10) there is no serious hematopoietic function, heart, lung, liver, kidney function abnormality and immune deficiency. 11) bone marrow and liver and kidney function: white blood cell count=3.5 X 10^9/L, neutrophil count = 1.5 X 10^9/L; platelet count = 100 X 10^9/L; hemoglobin = 90 g/L (not the case of blood transfusion; total bilirubin) 3 months.

Exclusion criteria

Exclusion criteria: 1) complete obstruction cannot eat liquid postoperative esophagus, esophageal perforation or hematemesis; 2) the following: cornplex uncontrolled angina and heart failure, a history of hospitalization for nearly 3 months; a history of myocardial infarction in nearly 6 months; there is a need to use of antibiotics for the treatment of acute bacterial or fungal infection of lesions; chronic obstructive pulmonary disease or other disease episodes requiring hospitalization; have AIDS disease or virus carriers. 3) there were second primary tumors (basal cell carcinoma of the skin, carcinoma in situ of the cervix, except for more than 3 years of tumor free survival after treatment); 4) female or male patients with fertility are not intended to receive contraceptive treatment and treatment. 5) distant metastasis of liver and lung organs; 6) chemotherapy, radiotherapy and targeted drug therapy were received 30 days before random grouping. 7) other experimental drugs or other clinical trials were used 30 days before random grouping. 8) drug addicts such as drug abuse, long term alcoholism, and AIDS patients; 9) there are non - controlled epileptic seizures, or people who have lost their knowledge of psychosis; 10) researchers think it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
local control rate;

Secondary

MeasureTime frame
over survial;toxic side effects;

Countries

China

Contacts

Public ContactYe Jinjun

Jiangsu Cancer Hospital

jjye2004@163.com+86 13585175433

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026