Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients (New Beat)

November 7, 2014 updated by: Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary endpoint: Pathological Complete Response Rate (pCR)

Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Sixth Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510600
        • Sixth Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ECOG status of 0 or 1.
  • 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 1.5.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.
  • Proteinuria at baseline or clinically significant impairment of renal function Subjects unexpectedly discovered to have 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 500 mg of protein/24 hr to allow participation in the study.
  • Currently has serious, nonhealing wound, ulcer, or bone fracture.
  • Had aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations within the past year.
  • Patients who have had an organ allograft.
  • Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete response rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: one year
one year
Time to progression
Time Frame: one year
one year
Time to relapse
Time Frame: one year
one year
Safety data of this regimen
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 11, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHMO-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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