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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
NCT02438839 |
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Date of registration:
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05/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Curative Chemoradiation of Low Rectal Cancer
WW2 |
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Scientific title:
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Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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105 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02438839 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Henrik Jensen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Oncology, Vejle Hospital |
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Name:
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Anders Jakobsen, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Oncology, Vejle Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histopathologically verified adenocarcinoma of the rectum
- Planned abdominoperineal resection (APR) or ultralow resection
- Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive
lymph nodes are localized to the mesorectum at the level of the tumor.
- Distance from anal verge to lower edge of tumor = 6 cm measured by rigid rectoscope
- Performance status 0-2
- Patient acceptance to collection of biopsies and blood samples for translational
research
- Age = 18 years
- Normal function of bone marrow as evaluated by
- neutrophils = 1.5 x 10^9/l
- thrombocytes = 100
- Normal function of liver
- alanine aminotransferase (ALAT) < 2.5 x upper limit of normal
- bilirubin < 2.5 x upper limit of normal
- Kidney function
- Serum creatinine < 1.5 x upper limit of normal or measured glomerular filtration
rate (GFR) > 30 ml/min
- Fertile women must present a negative pregnancy test and use secure contraceptives
during and 3 months after treatment.
- Written and orally informed consent
Exclusion Criteria:
- Previous surgical treatment of the present cancer, including transanal excision of
tumor.
- Other malignant disease within the past five years except basocellular skin cancer and
carcinoma in situ cervicis uteri
- Distant metastases verified by imaging or biopsy
- Previous radiation treatment of the pelvis
- Pregnant or breastfeeding women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rectal Cancer
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Primary Outcome(s)
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Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
[Time Frame: 2 years after end of treatment]
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Secondary Outcome(s)
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Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination
[Time Frame: 6 and potentially 12 weeks after end of treatment]
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Rate of distant metastases
[Time Frame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years]
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Cumulative incidence of local recurrence after surgery
[Time Frame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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