Clinical trial NCT03245203: A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
Official title: A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: neoadjuvant chemotherapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: R0 resection rate
timeFrame: 3 years
Secondary outcomes:
measure: disease-free survival (DFS)
timeFrame: 3 years
measure: overall survival (OS)
timeFrame: 3 years
measure: overall response rate (ORR)
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Affiliated Hospital, Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: First Affiliated Hospital, Chinese PLA General Hospital
name: nan du
role: PRINCIPAL_INVESTIGATOR
References: