NCT00506844

Brief Summary

This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

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

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 25, 2007

Status Verified

July 1, 2007

First QC Date

July 23, 2007

Last Update Submit

July 23, 2007

Conditions

Rectal NeoplasmsNeoadjuvant Treatment

Keywords

Rectal neoplasmsNeoadjuvant treatmentCetuximabIrinotecanCapecitabineRadiotherapyCombination chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic stage Tumor regression grade

    After operation

Secondary Outcomes (2)

  • Toxicity measured by NCICTC v3

    During chemoradiation

  • Disease-free survival

    Three year

Interventions

Cetuximab, Irinotecan, CapecitabineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma of the rectum
  • Distal margin of tumor located from 0 to 8 cm from anal verge
  • Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography
  • ECOG performance status 0-2
  • No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy
  • Adequate organ functions
  • Patients must sign the informed consent

You may not qualify if:

  • Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
  • Any defined hereditary colorectal cancer
  • Any unresected synchronous colon cancer
  • R0 resection of tumor is not clinically possible
  • Any distant metastasis
  • Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
  • Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
  • Any other morbidity or situation with contraindication for chemoradiotherapy
  • Patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
  • History of severe pulmonary disease
  • Pregnant or lactating women or patients of childbearing potential not predicting adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

CetuximabIrinotecanCapecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Kyung Hae Jung, M.D.Ph.D

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 25, 2007

Study Start

May 1, 2006

Study Completion

May 1, 2010

Last Updated

July 25, 2007

Record last verified: 2007-07

Locations

KR(4)