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Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer (XERT)

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Slovenia
Study Type
Interventional
Intervention
cetuximab, capecitabine
Sponsored by
Institute of Oncology Ljubljana
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring cetuximab, capecitabine, radiotherapy, rectal cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 80 if judged fit for surgery
  • WHO performance status 0-1
  • Histologically proven rectal adenocarcinoma located below the peritoneum
  • T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI
  • No distant metastases
  • Adequate haematological, cardiac, liver and renal function
  • Signed informed consent
  • Appropriate measures for contraception for men and women, if applicable

Exclusion Criteria:

  • Prior radio- and/or chemotherapy
  • Others synchronous cancers
  • History of other malignant disease
  • Significant heart disease
  • Known hypersensitivity to biological drugs
  • Pregnant or lactating patient

Sites / Locations

  • Institute of Oncology

Outcomes

Primary Outcome Measures

Complete pathological remission rate

Secondary Outcome Measures

Rate of sphincter sparing surgical procedure Toxicity/safety

Full Information

First Posted
May 30, 2008
Last Updated
March 23, 2012
Sponsor
Institute of Oncology Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT00689702
Brief Title
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer
Acronym
XERT
Official Title
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Oncology Ljubljana

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.
Detailed Description
Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
cetuximab, capecitabine, radiotherapy, rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cetuximab, capecitabine
Other Intervention Name(s)
Erbitux, Xeloda
Intervention Description
Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50). Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy. Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks.
Primary Outcome Measure Information:
Title
Complete pathological remission rate
Time Frame
at pathological examm of surgical speciment
Secondary Outcome Measure Information:
Title
Rate of sphincter sparing surgical procedure Toxicity/safety
Time Frame
Toxicity/safety:during preoperative treatment, early and late postoperative follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 if judged fit for surgery WHO performance status 0-1 Histologically proven rectal adenocarcinoma located below the peritoneum T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI No distant metastases Adequate haematological, cardiac, liver and renal function Signed informed consent Appropriate measures for contraception for men and women, if applicable Exclusion Criteria: Prior radio- and/or chemotherapy Others synchronous cancers History of other malignant disease Significant heart disease Known hypersensitivity to biological drugs Pregnant or lactating patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaneja Velenik, PhD, MD
Organizational Affiliation
Institute of Oncology, Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Oncology
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
15913913
Citation
Kim JC, Kim TW, Kim JH, Yu CS, Kim HC, Chang HM, Ryu MH, Park JH, Ahn SD, Lee SW, Shin SS, Kim JS, Choi EK. Preoperative concurrent radiotherapy with capecitabine before total mesorectal excision in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):346-53. doi: 10.1016/j.ijrobp.2005.02.046.
Results Reference
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PubMed Identifier
12908562
Citation
Grunwald V, Hidalgo M. Development of the epidermal growth factor receptor inhibitor Tarceva (OSI-774). Adv Exp Med Biol. 2003;532:235-46. doi: 10.1007/978-1-4615-0081-0_19.
Results Reference
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PubMed Identifier
17042060
Citation
Velenik V, Anderluh F, Oblak I, Strojan P, Zakotnik B. Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial. Croat Med J. 2006 Oct;47(5):693-700.
Results Reference
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PubMed Identifier
11432891
Citation
Robert F, Ezekiel MP, Spencer SA, Meredith RF, Bonner JA, Khazaeli MB, Saleh MN, Carey D, LoBuglio AF, Wheeler RH, Cooper MR, Waksal HW. Phase I study of anti--epidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. J Clin Oncol. 2001 Jul 1;19(13):3234-43. doi: 10.1200/JCO.2001.19.13.3234.
Results Reference
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Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer

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