search
Back to results

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

Primary Purpose

Locally Advanced Malignant Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
chemoradiation
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Malignant Neoplasm focused on measuring Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital, CAMSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

preoperative chemoradiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Pathological complete remission rate (pCR)
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)

Secondary Outcome Measures

Acute and late toxicity
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.

Full Information

First Posted
May 19, 2013
Last Updated
June 3, 2013
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01871363
Brief Title
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Official Title
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Malignant Neoplasm
Keywords
Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preoperative chemoradiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
chemoradiation
Other Intervention Name(s)
Preoperative Radiotherapy With Capecitabine and Bevacizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pathological complete remission rate (pCR)
Description
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)
Time Frame
after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary Outcome Measure Information:
Title
Acute and late toxicity
Description
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.
Time Frame
Toxicity/safety:during preoperative treatment, early and late postoperative follow up
Other Pre-specified Outcome Measures:
Title
Disease-free survival
Description
Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.
Time Frame
3 year afte concurrent chemoradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, professor
Phone
87788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Ren, attending
Phone
87788122
Email
renhua2009@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Jin, proffessor
Organizational Affiliation
Dept of Radiation oncology, Cancer hospital, CAMS
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital, CAMS
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Jin, proffessor
Phone
8610-87788280
Email
jingjin1025@163.com
First Name & Middle Initial & Last Name & Degree
Hua Ren, Attening
Phone
8610-87788122
Email
renhua2009@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jing Jin, professor

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs