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

NCT04679597 | Completed FDA Drug

• 1 other identifier: ERID-KSOPKR-0009/2019
• Study Type: observational
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete response

  pathological complete response is defined as the absence of tumor cells in the surgical resection

  during surgery

Secondary Outcomes (1)

• Neoadjuvant rectal cancer score

  during treatment, assessed up to 10 days

Other Outcomes (2)

• number of participants who completed treatment

  during treatment, assessed up to 10 days

• number of participants with acute side effects

  during treatment, assessed up to 10 days

Study Arms (2)

total neoadjuvant therapy

Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery.

Drug: Capecitabine

standard therapy

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Drug: Capecitabine

Interventions

Capecitabine DRUG

comparison of two treatments

Also known as: oxaliplatin

standard therapy; total neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all adult patients with newly diagnosed LARC with high risk factors for failure who were treated with TNT or standard therapy at the Institute of Oncology, Ljubljana, from 2016 to 2019

You may qualify if:

• 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.

You may not qualify if:

• distant metastases,
• concomitant malignancy,
• inflammatory bowel disease, or
• malabsorption syndrome.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 17, 2024

Record last verified: 2024-10