Observation of the Impact of Radiotherapy With or Without Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets for Patients With Thoracic Cancer

Shanghai Cancer Hospital, China1 site in 1 country500 target enrollmentJanuary 1, 2012

ConditionsNSCLC Esophageal Squamous Cell Carcinoma Thymic Epithelial Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: NSCLC
Sponsor: Shanghai Cancer Hospital, China
Enrollment: 500
Locations: 1
Primary Endpoint: Overall Survival
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.

Registry

clinicaltrials.gov

Start Date

January 1, 2012

End Date

December 2026

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai Cancer Hospital, China

Responsible Party

Principal Investigator

Fan Min

MD. PhD

Shanghai Cancer Hospital, China

Eligibility Criteria

Inclusion Criteria

•Age at least 18 years. ECOG PS 0-
•Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.
•Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.
•Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
•Signed informed consent for the use of fresh tumor biopsies before and during the treatment.
•Women of childbearing age and men must agree to use effective contraception during the trial.
•Adequate organ function within 1 week prior to the enrollment：
•Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;
•Adequate hepatic function: total bilirubin \< 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
•Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;

Exclusion Criteria

•Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
•Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
•Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.
•Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.

Outcomes

Primary Outcomes

Overall Survival

Time Frame: Five years

OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.