Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline

Completed

Started Feb 2009

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach

1 country

130 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.1 years study duration

First Submitted

Initial submission to the registry

May 28, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed

8 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

February 24, 2016

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed

Last Updated

May 18, 2018

Status Verified

April 1, 2018

Enrollment Period

5.4 years

First QC Date

May 28, 2008

Results QC Date

January 26, 2016

Last Update Submit

April 18, 2018

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectumstage IIA rectal cancerstage IIB rectal cancerstage IIC rectal cancerstage IIIA rectal cancerstage IIIB rectal cancerstage IIIC rectal cancer

Outcome Measures

Primary Outcomes (1)

Pathologic Complete Response Rate
Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.
15-20 weeks from registration

Secondary Outcomes (2)

3-year Disease-free Survival
3 years
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Up to 4 years

Study Arms (1)

Chemo + Chemo and radiation + Surgery

EXPERIMENTAL

Chemotherapy Cycle 1 (1 cycle is 35 days): * Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29 * Cetuximab, 400 mg/m\^2, IV, Day 1 * Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29 * Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35) Chemotherapy+ Radiation Cycle 2: * Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78 * Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78 * Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84) * Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions. Therapeutic Surgical procedure: Resection

Biological: cetuximabDrug: capecitabineDrug: oxaliplatinProcedure: therapeutic surgical procedureRadiation: radiation therapy

Interventions

cetuximabBIOLOGICAL

Chemotherapy cycle 1: Cetuximab, 400 mg/m\^2, IV, Day 1; Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29 Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78

Also known as: IMG-C225, Erbitux, NSC-714692