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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Thymic Epithelial Tumor; Esophageal Squamous Cell Carcinoma

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients diagnosed with NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Cancer Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2026

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: SHCH1501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No