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

NCT04522687 | Recruiting

• 1 other identifier: SHCH1501
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; Esophageal Squamous Cell Carcinoma; Thymic Epithelial Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression Free Survival

  Five years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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：
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Cancer Hospital, China: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Thymic epithelial tumor

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: January 1, 2012
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

CN (1)