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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02438839
Other study ID # WW2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2015
Est. completion date December 2024

Study information

Verified date May 2024
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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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