Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer

June 3, 2015 updated by: Yuan-hong Gao, Sun Yat-sen University
We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in locally advanced nonmetastatic rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may achieve promising improvements in pCR rates, we designed this Phase II study in patients with T3/4 or N1/2 loco-regionally advanced rectum cancer, to examine the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.

Study Type

Interventional

Enrollment (Anticipated)

45

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, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center (SYSUCC)
        • Contact:
          • Yuan-hong Gao
          • Phone Number: +86-20-87343385
        • Principal Investigator:
          • Yuan-hong Gao

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:

  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • T3 or T4 adenocarcinoma or node positive colorectal tumours.
  • Appropriate staging investigations of the primary tumour, either endorectal ultrasound or pelvic MRI.
  • Male or female aged 18 to 70.
  • Have a performance status ECOG of 0 or 1.
  • Have a life expectancy greater than 6 months.
  • Adequate organ function and coagulation parameters as measured by: WBC > 4000/mm3, PLT > 100000/mm3, Hb > 10g/dL, ALT < 1.5X ULN, AST < 1.5X ULN, bilirubin < 1.5mg/dL Serum creatinine < 1.8mg/dL.
  • Patient consent.

Exclusion Criteria:

  • Known to have clinical or radiological evidence of distant metastases.
  • Evidence of intestinal obstruction (except for those after enterostomy).
  • Patients with a past history of colorectal surgery (except for enterostomy), chemtherapy, radiation, biotherapy or targeted therapy.
  • Pregnant woman OR women of childbearing potential with a positive pregnancy test at baseline or lactating.
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  • Patients with a past or current history (within last 5 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix.
  • Patients with mental disorder unable to complete the informed consent.
  • Uncontrolled hypertension.
  • Clinically significant (i.e. active) cardiovascular disease for example:

cerebrovascular accidents (<=6 months), myocardial infarction (<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.

  • Moderate or serious proteinuria.
  • Known hypersensitivity against experimental drugs.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm

Neoadjuvant chemotherapy with XELOX: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 130mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1, during the first cycle (each cycle has 3 weeks).

Followed by chemoradiotherapy, 50 Gy/25 fractions during 5 weeks plus 2 cycles XELOX and Bevacizumab: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 100mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1.

6-7 weeks from the last radiation therapy, Total Mesorectal Excision (TME) surgery will be performed.

3-4 weeks after operation, 3 cycles XELOX (the same as the neoadjuvant chemotherapy) and 2 cycles Xeloda (po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning) will be administered.
Drug: Xeloda
po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
Other Names:
  • Capecitabine
Drug: Oxaliplatin
iv, 130mg/m2, day 1, 1 cycle during neoadjuvant chemotherapy and 3 cycles in adjuvant chemotherapy 100mg/m2, day 1, 2 cycles during concurrent chemoradiotherapy
Drug: Bevacizumab
iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy
Other Names:
  • Avastin
Radiation: Radiation
Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks
Procedure: surgery
Total Mesorectal Excision (TME)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pathologic tumor regression grade (TRG)
Time Frame: March 30, 2015
March 30, 2015

Secondary Outcome Measures

Outcome Measure
Time Frame
5-y overall survival
Time Frame: March 30, 2020
March 30, 2020
Occurence of toxicity
Time Frame: March 30, 2015
March 30, 2015
5-y local relapse free survival
Time Frame: March 30, 2020
March 30, 2020

Collaborators and Investigators

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

Sponsor

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, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

March 23, 2013

First Submitted That Met QC Criteria

March 23, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6901061

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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