Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: NSCLC, Esophageal Squamous Cell Carcinoma, Thymic Epithelial Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Overall Survival [Time frame: Five years]
Secondary outcome measures (1)
- Progression Free Survival [Time frame: Five years]
Eligibility criteria
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：
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT04522687 · SHCH1501