NCT04121975

CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer

Concurrent Chemoradiotherapy Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer, a Prospective, Single Arm Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.

Detailed description

This was a prospective, single arm, phase 2 trial. Adult Patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with Endostar. Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy. Endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. Cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. The primary endpoint was progression-free survival (PFS) rate at 1 year. The secondary endpoints were PFS, overall survival (OS) and safety.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
DRUG	Endostar	30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
DRUG	Cisplatin	30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-01
• Completion: 2022-08-01
• First posted: 2019-10-10
• Last updated: 2019-10-10

Locations

1 site across 1 country: China