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Clinical Trials/ISRCTN56463377
ISRCTN56463377
Completed
N/A

Pre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)

Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)0 sites760 target enrollmentJuly 2, 2007
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ConditionsRectal cancerCancerColorectal cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rectal cancer
Sponsor
Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)
Enrollment
760
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 2, 2007
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 18 years or over
  • •2\. Karnofsky Index 80% or better
  • •3\. Histological diagnosis of adeno\- or mucinous carcinoma of rectum
  • •4\. Primary rectal cancer:
  • •4\.1\. Maximum 12 cm above dentate line (upper limit)
  • •4\.2\. Staged T2N\+ or T3N0 or T3N\+ (by endorectal ultrasound or computed tomography \[CT]/magnetic resonance imaging \[MRI] scan)
  • •5\. No evidence of metastatic disease as determined by chest X\-ray and abdominal ultrasound (or CT\-scan of chest and abdomen or other investigations such as positron emission tomography \[PET] scan or biopsy if required)
  • •6\. Adequate bone marrow function with platelets more than 100 x 10^9/l and neutrophils more than 2\.0 x 10^9/l
  • •8\. Creatinine clearance more than 50 ml/min
  • •7\. Serum bilirubin less than 2\.0 x upper limit of institutional normal range (ULN)

Exclusion Criteria

  • •1\. Rectal cancer other than adeno\- or mucinous carcinoma
  • •2\. Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • •3\. Patients with locally advanced inoperable disease, such as T4\-tumour
  • •4\. Presence of metastatic disease or recurrent rectal tumour
  • •5\. Any previous chemotherapy or radiotherapy, and any investigational treatment for rectal cancer
  • •6\. Concurrent uncontrolled medical conditions
  • •7\. Pregnancy or breast feeding
  • •8\. Clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery) or myocardial infarction within the last six months
  • •9\. Stenotic tumour which can not be passed by the colonoscope and pre\-operative need of diverting stoma
  • •10\. Evidence of hereditary colorectal cancer (hereditary non\-polyposis colorectal cancer \[HNPCC] and familial adenomatous polyposis \[FAP])

Outcomes

Primary Outcomes

Not specified

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