Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

This study is not yet open for participant recruitment.
Verified July 2010 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01171300
First received: July 13, 2010
Last updated: August 10, 2010
Last verified: July 2010
  Purpose

Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.


Condition Intervention
Adenocarcinoma
Rectal Neoplasms
Other: 18F- FDG PET scans
Other: DW-MRI scans

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Pathologic complete response (ypT0N0) rate [ Time Frame: 6-8 weeks after the end of chemoradiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathologic downstaging (ypT0-2N0) rate and Tumour Regression Grade (TRG); according to Dworak et al. Response rate at time of surgery (RECIST criteria based on MRI); [ Time Frame: 6-8 weeks after the end of chemoradiotherapy ] [ Designated as safety issue: No ]
  • Quality of mesorectal excision. [ Time Frame: 6-8 weeks after the end of chemoradiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 18F- FDG PET scans
    We aim to investigate the value of FGD-PET for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
    Other: DW-MRI scans
    We aim to investigate the value of DW-MRI for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is at least 18 years of age.
  • Patient's body weight is ≤ 120 kg.
  • Histologically proven and evaluable (according to RECIST criteria) adenocarcinoma of the rectum (tumour <15 cm from the anal verge), staged T3-4 N0 and T1-4N1-2.
  • WHO PS ≤ 2
  • Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
  • Hemoglobin >10.0 g/dL,
  • Absolute neutrophil count > 1.5 x 109/L,
  • Platelet count > 100 x 109/L,
  • Presence of adequate contraception in fertile patients. Adequate methods of contraception are: intra-uterine device, hormonal contraception, condom use with spermicide.
  • Written informed consent must be given according to ICH/GCP and national/local regulations.

Exclusion Criteria:

  • Evidence of distant metastases.
  • Prior chemotherapy or radiotherapy for rectal cancer.
  • Pregnant or breastfeeding women.
  • Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease).
  • Known allergies to intravenous contrast agents.
  • Contra-indications for magnetic resonance imaging (metal implants, claustrophobia, etc. ).
  • Previous or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and non-melanoma skin cancer.
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171300

Contacts
Contact: Annelies Debucquoy, MSc, PhD +3216/34.62.82 annelies.debucquoy@med.kuleuven.be

Locations
Belgium
University Hospitals Gasthuisberg Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Annelies Debucquoy, MSc, PhD    +3216/34.62.82    annelies.debucquoy@med.kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Karin Haustermans, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Karin Haustermans, Department of Radiation Oncology, UZ Leuven
ClinicalTrials.gov Identifier: NCT01171300     History of Changes
Other Study ID Numbers: S52399
Study First Received: July 13, 2010
Last Updated: August 10, 2010
Health Authority: Belgium: Commissie Medische Ethiek van Universitaire Ziekenhuizen K.U.Leuven

Keywords provided by Universitaire Ziekenhuizen Leuven:
staged T3-4 N0 and T1-4N1-2
adenocarcinoma of the rectum
rectum

Additional relevant MeSH terms:
Rectal Diseases
Adenocarcinoma
Neoplasms
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014