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

NCT03523234 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-09-05

No results posted yet for this study

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

Interventions

DRUG

neoadjuvant chemotherapy

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

PROCEDURE

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

Lobectomy/total lung resection plus mediastinal lymph node dissection.

PROCEDURE

prophylactic cranial irradiation

prophylactic cranial irradiation (PCI) undergoing with adjuvant chemotherapy simultaneously

DRUG

Chemotherapy

etoposide with cisplatin/carboplatin

Sponsors & Collaborators

  • Peng Zhang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523234 on ClinicalTrials.gov