Rectal Cancer Clinical Trial
— WW2Official title:
Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study
Verified date | May 2024 |
Source | Vejle Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies. Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.
Status | Active, not recruiting |
Enrollment | 105 |
Est. completion date | December 2024 |
Est. primary completion date | March 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aalborg University Hospital | Aalborg | |
Denmark | Department of Surgery, Aalborg University Hospital | Aalborg | |
Denmark | Department of Oncology, Rigshospitalet | Copenhagen | |
Denmark | Department of Oncology, Vejle Hospital | Vejle | |
Denmark | Department of Surgery, Vejle Hospital | Vejle |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment | 2 years after end of treatment | ||
Secondary | Cumulative incidence of local recurrence after surgery | 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 | ||
Secondary | Rate of distant metastases | 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 | ||
Secondary | Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination | 6 and potentially 12 weeks after end of treatment |
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