NCT03245203

A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to reduce the local recurrence rate, however, no improvement of distant metastasis rate was observed, and the incidence of postoperative local recurrence and distant metastasis can reach more than 25%. It is still a challenge for us to improve the RO resection rate of locally advanced rectal cancer and reduce the incidence of local recurrence and distant metastasis.

Detailed description

Objective: compared with the postoperative adjuvant therapy, neoadjuvant chemotherapy has shown better compliance of LARC patients, and may be more effective in reducing the incidence of local recurrence and distant metastasis. This study used the anti-angiogenesis drugs beacizumab and chemotherapy in patients with LARC for neoadjuvant chemotherapy, and investigated the short-term efficacy to provide objective basis for the selection of neoadjuvant therapy. Methods: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	FOLFIRI+beacizumab	Eligible patients received bevacizumab 5.0 mg/kg followed by irinotecan 125mg/m2 combined with LV 200mg/m2 followed by 5-FU bolus 400mg/m2,then 5-FU infusion 2.4\~3.0g/m2 over a 46-h period.Those agents were given for a 2-week cycle.Treatment was administered for six cycles. LARC was reevaluated and operated after 4\~8 weeks.
PROCEDURE	CRT	total dose of radiotherapy was 40\~50Gy, a subdose of 1.8\~2Gy for continuous 5 weeks, 5 times/week.Then,5-FU infusion 400mg/m2 combined with LV 200mg/m2 over 24 h for 4 days/week during the first and fifth weeks of radiotherapy.Whereas,Capecitabine was administered orally at a dose of 825mg/m2 twice a day for 5 days of a week. Second staging and operation were performed in the sixth week after chemoradiotherapy.

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2017-08-10
• Last updated: 2017-08-10

Locations

1 site across 1 country: China