Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure

Rectal Cancer Clinical Trial

Official title:

Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679597
• Other study ID #: ERID-KSOPKR-0009/2019
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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