NCT00973193

Brief Summary

The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy. The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

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

Study Start

First participant enrolled

September 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

September 7, 2009

Last Update Submit

April 19, 2016

Conditions

Rectal Cancer

Keywords

rectumcolorectalcanceradenocarcinomaanti-EGFRmonoclonal antibodiesneoadjuvant therapypreoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response (pCR)

    11 weeks

Secondary Outcomes (1)

  • Safety, pathologic R0 resection, negative Circumferential Resection Margin, pathologic downstaging, tumor regression grade, quality of mesorectal excision, rate of sphincter-preservation, Disease-Free Survival, local control rate, translational research

    24 months

Study Arms (1)

panitumumab

EXPERIMENTAL
Drug: panitumumab

Interventions

panitumumabDRUG

intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days

Also known as: Vectibix
panitumumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG Performance Status 0-1
  • Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0
  • Wild-type KRAS
  • No prior pelvic irradiation
  • Normal bone marrow, hepatic, renal, cardiac functions
  • No secondary malignancy
  • No other active, uncontrolled disease
  • Signed informed consent

You may not qualify if:

  • KRAS mutation
  • Established or suspected metastasis
  • Prior pelvic irradiation
  • Previous exposure to EGFR-targeting therapies
  • Patients under any other investigational agent(s)
  • Concurrent systemic immune therapy, chemotherapy, hormone therapy
  • Drug and/or alcohol abuse
  • Grade 3 to 4 allergic reaction to any of the components of the treatment
  • History or presence of interstitial lung disease
  • Active, uncontrolled cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Institute Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint Luc - Université Catholique de Louvain

Brussels, 1200, Belgium

Location

Centre Hospitalier Notre Dame et Reine Fabiola

Charleroi, 6000, Belgium

Location

Centre Hospitalier de Jolimont-Lobbes

La Louvière, 7100, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Clinique et Maternité Saint Elizabeth

Namur, 5000, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

Clinique Universitaire de Mont Godinne

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Rectal NeoplasmsNeoplasmsAdenocarcinoma

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jean-Pascal H Machiels, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2009

First Posted

September 9, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2012

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

BE(8)