Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer

Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

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 Contact

Study Contact Backup

Study Locations

      • Beijing, China, 100021
        • Recruiting
        • Cancer hospital, CAMS
        • Contact:
        • Contact:
        • Principal Investigator:
          • jing jin, professor

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4 or any node positive disease (clinical stage according the TNM classification system)
  • No evidence of metastatic disease.
  • Age 18 - 65 years
  • Kps 80-100
  • No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
  • Normal hematological, hepatic and renal function, Ability to swallow tablets
  • Signed informed consent
  • Patients must be willing and able to comply with the protocol for duration of the study

Exclusion Criteria:

  • Malignancy of the rectum other than adenocarcinoma

    • Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
    • Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
    • Evidence of active peptic ulcer or upper GI bleeding
    • Evidence of bleeding diathesis or coagulopathy
    • Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin
    • Known hypersensitivity to biological drugs
    • Treatment with any investigational drug within 30 days before beginning treatment with the study drug
    • Pregnant or lactating patient

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: preoperative chemoradiation
  • radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel.
  • capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends),
  • bevacizumab: at dose 5 mg/kg on days -1, 15,31.
  • Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.
  • radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel.
  • capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends),
  • bevacizumab: at dose 5 mg/kg on days -1, 15, 31.
  • Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.
Other Names:
  • Preoperative Radiotherapy With Capecitabine and Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete remission rate (pCR)
Time Frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR)
after pathological examination of surgical speciments (6-8 weeks after chemoradiation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicity
Time Frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.

late toxicites will be assessed every 6 months from the third year after surgery.

Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 year afte concurrent chemoradiation
Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.
3 year afte concurrent chemoradiation

Collaborators and Investigators

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

Investigators

  • Study Chair: Jing Jin, proffessor, Dept of Radiation oncology, Cancer hospital, CAMS

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

October 1, 2012

Primary Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

May 19, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

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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