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

NCT03523234 | Unknown

• 1 other identifier: k18-066
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small-cell Lung Cancer

Keywords

neoadjuvant therapy; surgery

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival rate

  Five-year survival rate measures survival at 5 years after treatment.

  From the completion of the intervention to 5 years.

Secondary Outcomes (5)

• recurrence rate

  In 1 year after treatment.

• resection rate

  At the end of Perioperative period, an average of 2 weeks.

• tumor biological makers

  At the end of Perioperative period, an average of 2 weeks

• overall survival rate

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 months

• disease-free survival rate

  From date of randomization until the date of first documented progression, whichever came first, assessed up to 40 months

Study Arms (2)

surgery group

EXPERIMENTAL

Drug: neoadjuvant chemotherapy; Procedure: radical surgery for stage II and IIIA small cell lung cancer (SCLC); Procedure: prophylactic cranial irradiation; Drug: Chemotherapy

control group

PLACEBO COMPARATOR

Procedure: prophylactic cranial irradiation; Drug: Chemotherapy

Interventions

neoadjuvant chemotherapy DRUG

etoposide with cisplatin/carboplatin, undergoing in prior to the surgery

surgery group

radical surgery for stage II and IIIA small cell lung cancer (SCLC) PROCEDURE

Lobectomy/total lung resection plus mediastinal lymph node dissection.

surgery group

prophylactic cranial irradiation PROCEDURE

prophylactic cranial irradiation (PCI) undergoing with adjuvant chemotherapy simultaneously

control group; surgery group

Chemotherapy DRUG

etoposide with cisplatin/carboplatin

control group; surgery group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peng Zhang: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Neoadjuvant Therapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Peng Zhang, Doctor

CONTACT

+86 021 651 15006; zhangpeng1121@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of science and education department

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 14, 2018
• Study Start: October 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

CN (1)