Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05054959

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Led by Institute of Oncology Ljubljana · Updated on 2021-09-23

62

Participants Needed

1

Research Sites

340 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

CONDITIONS

Official Title

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed rectal adenocarcinoma
  • No distant metastases on CT scan (M0 disease)
  • At least one high-risk factor for recurrence on MRI, including T4 tumor (cT4), N2 disease (cN2), extramural venous invasion (cEMVI+), positive lateral lymph nodes, or tumor/lymph nodes 1 mm or less from mesorectal fascia (cMRF+)
  • Ability to provide informed consent
  • Willingness to attend regular check-ups during and after treatment
Not Eligible

You will not qualify if you...

  • History of previous radiation therapy in the pelvic area
  • Absolute contraindications for MRI
  • Distant metastases cannot be reliably excluded
  • Presence of synchronous cancer
  • Chronic inflammatory bowel disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Oncology

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

V

Vaneja Velenik, PhD

CONTACT

M

Miha Orazem, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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