Status:
ACTIVE_NOT_RECRUITING
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Adenocarcinoma
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01171300
Start Date
October 1 2010
End Date
December 1 2025
Last Update
July 10 2024
Active Locations (1)
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1
University Hospitals Gasthuisberg
Leuven, Vlaams-Brabant, Belgium, 3000