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

NCT ID: NCT03245203

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2020-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)

Group Type: EXPERIMENTAL

FOLFIRI+beacizumab

Intervention Type: PROCEDURE

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.

Control group

neoadjuvant CRT for consecutive 5 weeks

Group Type: ACTIVE_COMPARATOR

CRT

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. Clinical stage II or stage III rectal cancer patients diagnosed by preoperative biopsy pathology report, endoscopic examination report and preoperative abdominal pelvic dynamic contrast enhanced-MRI examination (DCE-MRI); 2. Primary tumor lesions within 4~12 cm from the anus through endoscopic examination; 3. No distant metastasis and intestinal obstruction; 4. No surgical contraindications; 5. Can be treated with neoadjuvant chemotherapy confirmed by normal routine examination; 6. informed consent with patients and family members before treatment.

Exclusion Criteria

• history of beacizumab allergy, being treated with other therapy important viscera dysfunction and severe heart disease, including congestive heart failure, arrhythmia beyond the control, long-term drug treatment of angina pectoris, heart valve disease, myocardial infarction, and resistant hypertension; infectious wound and uncontrollable history of mental illness; infectious sexual diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

DuNan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nan du

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Chinese PLA General Hospital

Locations

First Affiliated Hospital, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

nan du

Role: CONTACT

dunan304@163.com

13911599657

Other Identifiers

20170801001

Identifier Type: -

Identifier Source: org_study_id