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Clinical Trials/DRKS00030567
DRKS00030567
Recruiting
未知

Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial - SELREC

niversitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie0 sites1,074 target enrollmentMarch 31, 2023
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ConditionsC20Malignant neoplasm of rectum

Overview

Phase
未知
Intervention
Not specified
Conditions
C20
Sponsor
niversitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Enrollment
1074
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 31, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Eligibility Criteria

Inclusion Criteria

  • •Primary adenocarcinoma of the rectum \<12cm from the anal verge
  • •\- T3 and/or N1 disease
  • •\- CRM \>1mm (MRI based)
  • •\- No evidence of distant metastasis (M0\)
  • •\- Age \=18 years
  • •\- Ability of patient subject to understand character and individual consequences of the clinical trial
  • •\- Written informed consent

Exclusion Criteria

  • •\- Patients who should not receive multimodal treatment for safety reasons
  • •\- Patients needing neoadjuvant treatment for sphincter preservation
  • •\- Previous radiotherapy to the small pelvis
  • •\- Patients with extensive lymph node spread (N2\)
  • •\- Extramural vascular invasion or tumour deposits
  • •\- Participation in another interventional trial with interference of intervention and/or outcome of this trial
  • •\- Previous diagnosis of malignant disease except basal cell carcinoma
  • •\- Contraindications for MRI (e.g. non\-MRI\-compatible cardiac pacemaker)
  • •\- Pregnancy or lactation
  • •\- Any condition that could result in an undue risk for the patient based on the investigator’s assessment

Outcomes

Primary Outcomes

Not specified

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