Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Small Cell Lung Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combine...

The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems. While there still is no consensus on second-line therapy. Clinical studies have demonstrated that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed cross-resistance to carboplatin and cisplatin. Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models, which overcomes some forms of cisplatin or carboplatin resistance in preclinical tumour models. Retrospective studies also have demonstrated the efficacy of Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent SCLC.

Tracking Information

NCT #
NCT03613753
Collaborators
Not Provided
Investigators
Principal Investigator: ShengFa Su, PhD,MD The Affiliated Hospital Of Guizhou Medical University