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

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Xeloda

Oxaliplatin

Bevacizumab

Radiation

surgery

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Bevacizumab, capecitabine, oxaliplatin, preoporative IMRT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen University Cancer Center (SYSUCC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

The pathologic tumor regression grade (TRG)

Secondary Outcome Measures

5-y overall survival

Occurence of toxicity

5-y local relapse free survival

Full Information

NCT ID

NCT01818973

First Posted

March 23, 2013

Last Updated

June 3, 2015

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01818973

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

Rectal Cancer, Bevacizumab, capecitabine, oxaliplatin, preoporative IMRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Xeloda

Other Intervention Name(s)

Capecitabine

Intervention Description

po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks

Intervention Type

Procedure

Intervention Name(s)

surgery

Intervention Description

Total Mesorectal Excision (TME)

Primary Outcome Measure Information:

Title

The pathologic tumor regression grade (TRG)

Time Frame

March 30, 2015

Secondary Outcome Measure Information:

Title

5-y overall survival

Time Frame

March 30, 2020

Title

Occurence of toxicity

Time Frame

March 30, 2015

Title

5-y local relapse free survival

Time Frame

March 30, 2020

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuanhong Gao

Phone

+86-20-87343385

gaoyh@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center (SYSUCC)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan-hong Gao

Phone

+86-20-87343385

First Name & Middle Initial & Last Name & Degree

Yuan-hong Gao

12. IPD Sharing Statement

Citations:

PubMed Identifier

29784042

Citation

Yu X, Wang QX, Xiao WW, Chang H, Zeng ZF, Lu ZH, Wu XJ, Chen G, Pan ZZ, Wan DS, Ding PR, Gao YH. Neoadjuvant oxaliplatin and capecitabine combined with bevacizumab plus radiotherapy for locally advanced rectal cancer: results of a single-institute phase II study. Cancer Commun (Lond). 2018 May 21;38(1):24. doi: 10.1186/s40880-018-0294-z.

Results Reference

derived

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

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