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Clinical Trials/NL-OMON50184
NL-OMON50184
Recruiting
Phase 3

Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers. - TESAR Trial

Amsterdam UMC, locatie VUmc0 sites302 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Amsterdam UMC, locatie VUmc
Enrollment
302
Status
Recruiting
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
Amsterdam UMC, locatie VUmc

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM,
  • •EMR/ESD/endoscopic intramuscular dissection or polypectomy) of an early rectal
  • •cancer without carcinoma in the resection plane.
  • •2\. Patients without carcinoma in the resection plane or in case of unreliable
  • •resection planes (EMR/ESD) no macroscopic residual tumour confirmed by
  • •endoscopy are eligible for randomisation.
  • •3\. Only lesions for which TME surgery is indicated can be included (If a
  • •partial mesorectal excision (PME) is indicated the patient should be excluded).
  • •4\. Pathological confirmation of the rectal adenocarcinoma fulfilling the
  • •following criteria: T1 with size 3\-5 cm of carcinoma or pT1, maximum size of

Exclusion Criteria

  • •1\. Incomplete or inconclusive resection margin with macroscopic residual tumour.
  • •2\. T1 tumour with carcinoma \< 3 cm, moderate/well differentiated, without
  • •sm3/Haggit 4,tumour budding, venous or lymphatic invasion.
  • •3\. T1 tumour with carcinoma of \>5 cm and T2 tumour with carcinoma of \> 3 cm.
  • •4\. Presence of metastatic disease or recurrent rectal tumour.
  • •5\. Previous pelvic radiation.
  • •6\. Treatment with any other investigational agent, or participation in another
  • •clinical trial that interferes with the outcomes within 28 days prior to
  • •7\. Concomitant malignancies, except for adequately treated basocellular
  • •carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with

Outcomes

Primary Outcomes

Not specified

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