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Clinical Trials/NL-OMON41313
NL-OMON41313
Completed
Not Applicable

Pilot study evaluating the feasibility of endoscopy guided fiducial marker placement for rectal cancer. - Endoscopy guided fiducial marker placement for rectal cancer.

Antoni van Leeuwenhoek Ziekenhuis0 sites20 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Enrollment
20
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Antoni van Leeuwenhoek Ziekenhuis

Eligibility Criteria

Inclusion Criteria

  • •Histologically proven diagnosis of primary rectal adenocarcinoma
  • •Treatment plan:
  • •o 5x5 Gray (Gy) neoadjuvant radiotherapy followed by TME
  • •\* cT1\-3N1 / cT3N0 with extramural invasion \>5 mm
  • •\* Distance to mesorectal fascia \>1 mm
  • •o Chemoradiation consisting of 25 x 1,8 Gy combined with Capecitabine 825 mg/m2 twice daily followed by TME
  • •\* cT4 / cT2\-3 with distance to mesorectal fascia \<\=1 mm
  • •\* cN2 / extramesorectal pathological lymph nodes
  • •o 5x5 Gy RT followed by chemotherapy (with or without a subsequent TME)
  • •\* rectal cancer with resectable liver metastases

Exclusion Criteria

  • •Coagulopathy (prothrombin time \< 50% of control; partial thromboplastin time \> 50 seconds) or anticoagulantia (marcoumar, sintrom or new oral anticoagulants) that cannot be stopped
  • •Prior pelvic irradiation or surgery that may affect the placement of the markers
  • •World health organization performance status 3\-4
  • •Pregnant women
  • •Patients who underwent a hip replacement
  • •Patients with a contraindication for MRI (e.g. pacemaker, metallic foreign body in the eye, cerebral aneurysm clips, claustrophobia)

Outcomes

Primary Outcomes

Not specified

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