~3 spots leftby Apr 2026

Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer

Recruiting in Palo Alto (17 mi)
+106 other locations
JC
Overseen byJerome C Landry
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Prior Safety Data
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well giving bevacizumab, radiation therapy, and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

Research Team

JC

Jerome C Landry

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Inclusion Criteria

Patients must have histologically confirmed, locally advanced, non-metastatic primary T3 or T4 adenocarcinoma of the rectum
Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
Patients must not have intra-operative radiotherapy (IORT) or brachytherapy treatment to the pelvis
See 7 more

Treatment Details

Interventions

  • Bevacizumab (Monoclonal Antibodies)
  • Capecitabine (Chemotherapy)
  • Fluorouracil (Chemotherapy)
  • Leucovorin Calcium (Chemotherapy)
  • Oxaliplatin (Chemotherapy)
  • Radiation Therapy (Radiation)
  • Therapeutic Conventional Surgery (Surgery)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (bevacizumab and chemoradiotherapy)Experimental Treatment7 Interventions
See Detailed Description

Capecitabine is already approved in Canada, Japan for the following indications:

🇨🇦
Approved in Canada as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇯🇵
Approved in Japan as Xeloda for:
  • Colorectal cancer
  • Breast cancer

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Licking Memorial HospitalNewark, OH
Springfield Regional Medical CenterSpringfield, OH
Genesis Healthcare System Cancer Care CenterZanesville, OH
Froedtert and the Medical College of WisconsinMilwaukee, WI
More Trial Locations
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Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14080
Patients Recruited
41,180,000+