Neoadjuvant Therapy Combined With Radical Surgery for the Treatment of Small Cell Lung Cancer (SCLC) in II and IIIA Stage

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to compare the effects of neoadjuvant with radical surgery on the prognosis of patients with stage II and IIIA small cell lung cancer (SCLC). The primary endpoint of this study is to observe 5-year survival, disease-free survival (DFS), and overall survival (OS) in patients. Secondary efficacy indicators include recurrence rate, surgical complications, resection rate, quality of life (QoL), and exploration biomarker (tumor tissue).

This is a two-arm, open, multicentral clinical study designed to assess the disease-free survival (DFS) and overall survival (OS) of neoadjuvant chemotherapy plus radical surgery for stage II and IIIA small cell lung cancer (SCLC). About 300 patients will be enrolled in the study and randomly divided into two groups of 150 individuals. The neoadjuvant with radical surgery group received 2 to 4 cycles of neoadjuvant treatment with etoposide plus cisplatin/carboplatin before receiving radical surgery, followed by 2 to 4 cycles of adjuvant chemotherapy (etoposide with cisplatin/carboplatin) plus radiotherapy. Patients in the control group are planned to receive 4 to 6 courses of etoposide plus cisplatin/carboplatin for chemotherapy and radiotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peng Zhang

Criteria

Inclusion Criteria:

• signed informed consent;

• Ability to comply with research protocols and follow-up procedures;

• The patient's age is 18 years or older;

• Histologically or cytologically confirmed as SCLC, chest-enhanced CT, liver and adrenal CT, cranial magnetic resonance, PET-CT/systemic bone imaging, etc. Definitely stage II, IIIA staged patients (according to the UICC 2009 edition staging criteria);

• Patients must have measurable lesions (according to the RECIST 1.0 standard);

• Physical status ECOG score is 0~1;

• Life expectancy is at least 12 weeks;

• The following laboratory tests were performed within 7 days prior to the first dose to confirm that the patient's bone marrow, liver, and kidney functions met the requirements for participating in the study:

• Hemoglobin ≥ 9.0 g/dL (can be maintained or exceeded by blood transfusion);

• The absolute neutrophil count (ANC) ≥ 1.5 × 109;

• platelet count ≥100×109/mm3;

• Total bilirubin ≤ 1.5 times the upper limit of normal;

• Alanine aminotransferase and aspartate aminotransferase ≤2.5 times the normal upper limit;

• creatinine ≤ 1.5 times the upper limit of normal; and creatinine clearance ≥ 60 ml/min;

• The international normalized prothrombin time ratio (INR) is less than 1.5 in patients who have not received anticoagulant therapy, and the partial thromboplastin time (APTT) is less than 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy should be stable for at least 2 weeks before entry into clinical studies, and the results of the clotting test can be entered into clinical trials within the limits of local treatment.

• Women of childbearing age must have a pregnancy test within 7 days of starting treatment and the result is negative.

• Men and women of appropriate age must have reliable methods of contraception prior to entering the trial and during the study until 30 days after discontinuation. Reliable contraceptive methods will be determined by the principal investigator or designated person.

Exclusion Criteria:

• Conducted any systemic anti-cancer therapy for SCLC, including cytotoxic drug therapy, targeted drug therapy, and experimental therapy;

• Surgical treatment for SCLC;

• Localized radiotherapy for SCLC;

• Patients with other than SCLC cancer in the five years prior to the start of treatment in this study. Except for cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including Ta and Tis];

• Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris starting in the last 3 months, congestive heart failure (≥New York Heart Association [NYHA] Grade II), myocardial infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease;

• Has or is currently suffering from interstitial lung disease;

• There are no fully controlled eye inflammations or eye infections, or any condition that may lead to the aforementioned eye diseases;

• Human immunodeficiency virus (HIV) infection is known;

• Allergies to any of the research drugs;

• Patients who have undergone major surgery or severe trauma within the first 2 months of the first dose;

• any malabsorption;

• pregnant or lactating women;

• Other investigators think it inappropriate to join the group.