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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
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

July 13, 2010
August 10, 2010
October 2010
October 2013   (final data collection date for primary outcome measure)
Pathologic complete response (ypT0N0) rate [ Time Frame: 6-8 weeks after the end of chemoradiotherapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01171300 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Adenocarcinoma
  • Rectal Neoplasms
  • 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))
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
October 2014
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Annelies Debucquoy, MSc, PhD +3216/34.62.82 annelies.debucquoy@med.kuleuven.be
Belgium
 
NCT01171300
S52399
Yes
Prof. Karin Haustermans, Department of Radiation Oncology, UZ Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Karin Haustermans, MD, PhD Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP