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Role of Short-Term Radiotherapy in Cancer of Large Bowel

Phase 2
Conditions
Rectal Adenocarcinoma.
Malignant neoplasm of rectum
Registration Number
IRCT2016121424266N2
Lead Sponsor
Deputy of Research, Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Inclusion Criteria:
Rectal Adenocarcinoma Confirmed by Pathology; Both Genders; Ages 18 to 80; Clinical Stages T3-4 or Lymph node Positive by MRI or Endosonography; Tumor Location 5 to 15 cm above anal verge; Good Performance Status (Eastern Cooperative Oncology Group 0-1)

Exclusion Criteria

Concurrent Malignancy other than Rectal Cancer; No tolerance for Chemotherapy; Previous Pelvic Radiotherapy; Distant Metastasis; Impaired Renal Function.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Complications. Timepoint: At the Initiation of Radiotherapy up to one month after surgery. Method of measurement: Common terminology criteria for cancer related therapy adverse events.
Secondary Outcome Measures
NameTimeMethod
Tumor Downstaging. Timepoint: After Surgery. Method of measurement: Pathology Report.;Node Downstaging. Timepoint: After Surgery. Method of measurement: Pathology Report.;Pathologic Response. Timepoint: After Surgery. Method of measurement: Based on Pathology Report.
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