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NCT Number: NCT04522687

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Min Fan, MD

CONTACT

[email protected]

18017312298

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression Free Survival

    Time frame: Five years

    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

Sponsors and collaborators

Lead sponsor

Shanghai Cancer Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2023
Study completion
2026
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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