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

Rectal Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01818973
• Other study ID #: 6901061
• Status: Recruiting
• Phase: Phase 2
• First received: March 23, 2013
• Last updated: June 3, 2015
• Start date: March 2013
• Est. completion date: March 2020

Study information

• Verified date: June 2015
• Source: Sun Yat-sen University
• Contact: Yuanhong Gao
• Phone: +86-20-87343385
• Email: gaoyh[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China:Institutional Review Board of Sun Yat-sen University Cancer Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2020
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Drug:
• Xeloda
po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
• 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
• Bevacizumab
iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy

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

Procedure:
• surgery
Total Mesorectal Excision (TME)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center (SYSUCC)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathologic tumor regression grade (TRG)		March 30, 2015	No
Secondary	5-y overall survival		March 30, 2020	No
Secondary	Occurence of toxicity		March 30, 2015	Yes
Secondary	5-y local relapse free survival		March 30, 2020	No