Phase II Trial of Neoadjuvant Chemoradiation With Bevacizumab for Chinese Locally Advanced Rectal Adenocarcinoma

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country25 target enrollmentMarch 2012

ConditionsRectal Adenocarcinoma

DrugsBevacizumab Oxaliplatin 5-FU

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Rectal Adenocarcinoma
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment: 25
Locations: 1
Primary Endpoint: Pathological complete response rate
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma.

Detailed Description

Primary endpoint: Pathological Complete Response Rate (pCR) Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party

Principal Investigator

Jian Xiao

Principal Investigator

Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•ECOG status of 0 or
•All patients must have histologically confirmed adenocarcinoma of the rectum. The clinical stage must be T3, T4, or regional lymphnode involvement based on CT, MRI or EUS criteria. Criteria for pathologic enlargement of lymph nodes is \> 15 mm on short axis dimension. If CT findings of lung, liver, or peritoneal metastases are equivocal, patients are eligible to participate.
•All patients must have no distant metastatic disease on abdominopelvic CT scan performed with IV contrast.
•The rectal tumor must be either palpable on digital rectal exam or the inferior edge of the tumor must be within 12 cm of the anal verge based on rigid proctoscopy.
•Patients must have WBC \> 4\*10E9/L, ANC of \> 1.5 \*10E9/L, platelets \> 100\*10E9/L, Hemoglobin of \> 90 g/L and adequate hepatic and renal function.
•Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.

Exclusion Criteria

•Known compromised renal or hepatic function.
•Participation in any other experimental drug study.
•AST or ALT \> 5 times upper limit of normal for subjects with documented liver metastases; \> 2.5 times the upper limit of normal for subjects without evidence of liver metastases.
•Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman/men of childbearing potential not using a reliable contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
•Any prior chemotherapy.
•Any prior radiation therapy.
•Serious, uncontrolled, concurrent infection(s) requiring IV antibiotics.
•Treatment for other carcinomas within the last five years, except cure non-melanoma skin cancer and treated in-situ cervical cancer.
•Clinically significant cardiac disease (e.g., uncontrolled hypertension \[blood pressure of \> 160/110 mmHg on medication\], any history of myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix H), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or grade II or greater peripheral vascular disease(see Appendix H).
•Evidence of bleeding diathesis or coagulopathy, INR greater than or equal to 1.