Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522687
• Other study ID #: SHCH1501
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 2026

Study information

• Verified date: August 2020
• Source: Shanghai Cancer Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age at least 18 years. ECOG PS 0-1. 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:

1. 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;

2. 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;

3. 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.

Related Conditions & MeSH terms

• Esophageal Squamous Cell Carcinoma
• NSCLC
• Thymic Epithelial Tumor

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Cancer Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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.	Five years
Secondary	Progression Free Survival	PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first	Five years