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

Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01171300
• Other study ID #: S52399
• Status: Active, not recruiting
• Phase: N/A
• First received: July 13, 2010
• Last updated: December 3, 2015
• Start date: October 2010
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Commissie Medische Ethiek van Universitaire Ziekenhuizen K.U.Leuven
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Neoplasms

Intervention

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))
• 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))

Locations

Country	Name	City	State
Belgium	University Hospitals Gasthuisberg	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response (ypT0N0) rate		6-8 weeks after the end of chemoradiotherapy	No
Secondary	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);		6-8 weeks after the end of chemoradiotherapy	No
Secondary	Quality of mesorectal excision.		6-8 weeks after the end of chemoradiotherapy	No

External Links

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