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Clinical Trials/DRKS00020770
DRKS00020770
Completed
Phase 3

Short-term radiotherapy versus chemoradiotherapy followed by consolidating chemotherapy and selective organ preservation for Patients with MRI-defined intermediate and high risk - ACO/ARO/AIO-18.1

Klinik für Strahlentherapie Universitätsklinikum Frankfurt/M0 sites702 target enrollmentFebruary 7, 2020
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ConditionsC20Malignant neoplasm of rectum

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
C20
Sponsor
Klinik für Strahlentherapie Universitätsklinikum Frankfurt/M
Enrollment
702
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 7, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinik für Strahlentherapie Universitätsklinikum Frankfurt/M

Eligibility Criteria

Inclusion Criteria

  • •Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma, localized 0 \- 12 cm from the anocutaneous line, measured by rigid rectoscopy (i.e. lower and
  • •middle third of the rectum)
  • •Staging requirements: The high\-resolution, Thin\-slice (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
  • •MRI\-Defined Inclusion Criteria: Presence at least one of the following high risk conditions:
  • •\- each cT3 if the distal extent of the tumor \<6 cm from the anocutaneous line, or
  • •\- cT3c / d in the middle third of the rectum (\= 6\-12 cm) with MRI evidence of extramural spread Tumor in the mesorectal fat of more than 5 mm (\> cT3b), or
  • •\- cT3 with clear cN \+ based on strict MRI criteria (see appendix)
  • •cT4 tumors, or
  • •\- each T middle / low third of the rectum with clear MRI criteria for N \+
  • •\- mrCRM \+ (\= 1mm), or

Exclusion Criteria

  • •The lower edge of the tumor is more than 12 cm from the anocutaneous line, measured through rigid rectoscopy
  • •Distant metastases (to be excluded by CT scan of Thorax and abdomen)
  • •Previous antineoplastic therapy for rectal cancer
  • •Prior radiotherapy to the pelvic region
  • •Major surgery within the last 4 weeks before the recording
  • •Pregnant or breastfeeding women or women who plan during the study or within up to 6 Getting pregnant months after completing your studies
  • •Men or women who are not too consistent Contraceptive measures with a reliable method during the study and up to 6 months after the end willing or able to study
  • •Simultaneous participation in a clinical study within 30 days of inclusion in the study
  • •Previous or current drug abuse
  • •Other concomitant antineoplastic therapy

Outcomes

Primary Outcomes

Not specified

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