NCT04017377

VMAT Concurrent Cisplatin Plus Nab-paclitaxel for Local Advanced Cervical Cancer

Study of Radiation Therapy With Concomitant Nab-paclitaxel and Cisplatin Chemotherapy in Patients With Locally Advanced Cervical Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-lable Phase I clinical trial. Eligible patients will have Histologically proven stage IB2-IVA cervical cancer. We hypothesize that Nab-paclitaxel in combination with cisplatin and radiotherapy may have anti-tumor activity in patients with cervical cancer. Nab-paclitaxel has not previously been combined with conventional RT-CT to treat cervical cancer.

Detailed description

During the phase I study, patients will receive radiation therapy to pelvis (50.4 Gy in 28fractions), and followed by HDR intracavitary (30Gy in 5 fractions) brachytherapy. Concurrent chemotherapy was administered with weekly cisplatin (40 mg/m\^2) and an escalating dose of weekly Nab-paclitaxel starting at 10 mg/m\^2 up to 70 mg/m\^2. Chemotherapy agents were administered in escalating doses to cohorts of three patients at each dose level.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Drug: Cisplatin; nab-paclitaxel	Drug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-06-15
• Completion: 2020-07-15
• First posted: 2019-07-12
• Last updated: 2020-04-28

Locations

1 site across 1 country: China