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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04679597
Other study ID # ERID-KSOPKR-0009/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2019

Study information

Verified date December 2020
Source Institute of Oncology Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - histologically proven locally advanced rectal cancer and - the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node. Exclusion Criteria: - distant metastases, - concomitant malignancy, - inflammatory bowel disease, or - malabsorption syndrome.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Capecitabine
comparison of two treatments

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institute of Oncology Ljubljana

Outcome

Type Measure Description Time frame Safety issue
Other number of participants who completed treatment Compliance - number of participants who completed treatment protocol during treatment, assessed up to 10 days
Other number of participants with acute side effects Acute toxcity - number of participants with side effects during different treatment modality during treatment, assessed up to 10 days
Primary pathological complete response pathological complete response is defined as the absence of tumor cells in the surgical resection during surgery
Secondary Neoadjuvant rectal cancer score Neoadjuvant rectal cancer score: The NAR score was calculated using the equation [5 pN - 3(cT - pT) + 12]^2 / 9.61 and further classified as low (< 8), intermediate (8-16), or high (< 16). during treatment, assessed up to 10 days
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