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Clinical Trials/NL-OMON29980
NL-OMON29980
Not yet recruiting
Phase 2

Preoperative short-term radiotherapy for primary resectable rectal cancer: Accelerated once daily (5x5Gy) versus accelerated hyperfractionated twice daily (12x2,5Gy b.i.d.) (ONCE-TWICE trial) A phase II single-blinded multi-institutional randomised study - ONCE-TWICE trial

niversitair Medisch Centrum Groningen0 sites210 target enrollmentTBD
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Conditionsbowel cancerrectal cancer10017991

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
bowel cancer
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
210
Status
Not yet recruiting
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

Eligibility Criteria

Inclusion Criteria

  • •\- Primary resectable rectal cancer. All patients with primary resectable rectal cancer are eligible for the study, regardless whether a low anterior resection with primary anastomosis or an abdominoperineal resection is planned.
  • •\- Histologically proven adenocarcinoma
  • •\- No distant metastases
  • •\- No prior radiotherapy to the pelvis or abdomen
  • •\- Age \>18 years
  • •\- WHO performance score 0\-2
  • •\- Patients at reproductive age must agree to practice an effective contraceptive method
  • •\- Written informed consent

Exclusion Criteria

  • •\- Non\-resectable rectal cancer (or resectability uncertain)
  • •\- Histology other than adenocarcinoma
  • •\- Distant metastases
  • •\- Pregnancy or lactation
  • •\- Psychological, familial, sociological or geographical reasons hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial

Outcomes

Primary Outcomes

Not specified

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