Status:

RECRUITING

Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer

Lead Sponsor:

Helsinki University Central Hospital

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

Rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. In 2017, there were 1221 new rectal cancers in Finland. The prognosis of colorectal cancer (CRC) patient...

Eligibility Criteria

Inclusion

  • rectal adenocarcinoma,
  • World Health Organization (WHO) performance status 0-1, assessed by the MDT to be able to undergo capecitabine and oxaliplatin (CAPOX) treatment, 3) extramural vein invasion by magnetic resonance imaging (mrEMVI+) and
  • 4\) assessed by the multi-disciplinary team (MDT) to require either radiotherapy (RT) or long chemoradiotherapy (CRT) by the current standards.

Exclusion

  • deficient mismatch repair (MMR) status,
  • non-dihydropyrimidine dehydrogenase (DPYD) genotype,
  • a contraindication to capecitabine, oxaliplatin or RT, or
  • failing in blood tests that describe the adequate circulatory, liver and kidney function for chemotherapy.

Key Trial Info

Start Date :

December 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

93 Patients enrolled

Trial Details

Trial ID

NCT04842006

Start Date

December 20 2021

End Date

December 31 2031

Last Update

March 6 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Helsinki University Central Hospital

Helsinki, Uusimaa, Finland, 00029

2

Tampere University Hospital

Tampere, Finland, 33520