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Clinical Trials/NL-OMON44829
NL-OMON44829
Completed
Not Applicable

RandomizEd Controlled Trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer. - RECTAL BOOST study

niversitair Medisch Centrum Utrecht0 sites142 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
142
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\* Participant in the PLCRC project (METC 12\-510\).
  • •\* Informed consent obtained for being offered experimental interventions within the PLCRC project.
  • •\* Informed consent obtained for questionnaires on patient reported outcomes within the PLCRC project.
  • •\* WHO: 0\-2\.
  • •\* T3\+ (circumferential resection margin (CRM) positive) T4N0\-1 or N2 M0\-1 (if resectable liver and/or lung metastases).
  • •\* Referred for chemoradiation.
  • •\* No contra\-indication for MRI.
  • •\* Tumor distance from ano\-rectal transition \*10cm.

Exclusion Criteria

  • •\* T3 (limited volume / CRM negative).
  • •\* Inflammatory bowel disease.
  • •\* Prior pelvic radiotherapy.
  • •\* At least one contra\-indication for capecitabine administration (based on DPD\-deficiency, blood count, liver malfunction, renal failure (Creatinine clearance \<30ml/min, medical history such as recent cardiac events).
  • •\* Recent pregnancy \*1 year ago.
  • •\* Inadequate understanding of the Dutch language in speech and/or writing.

Outcomes

Primary Outcomes

Not specified

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