Rectal cancer. Rectal and anal canal neoplasms
Conditions
Interventions
All patients will receive three fractions of 5 Gy endorectal brachytherapy, each spaced apart by 4 days (+/- 1 day) and during 2 weeks. Subsequently, this treatment will be followed by chemoradiation
Treatment - Other
Sponsors
Vice chancellor for research,, Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: • Pathologically proved adenocarcinoma of the rectum • Age 18 or older • Clinically staged II-III tumor by MRI and/or EUS • ECOG performance status of 0 or 1 • Tumors located at up to10 cm of the anus • No previous history of malignancy, pelvic radiotherapy or chemotherapy • Normal or adequate bone marrow reserve • Normal or adequate liver and kidney function • Exclusion Criteria: • Patients with tumors >12 cm from the anal verge. • Near obstructing or bulky tumors which will not allow application of the endorectal applicator before or after chemoradiation • Patients with distant metastatic disease • Prior history of radiation therapy to the pelvis • Prior history of chemotherapy for rectal cancer • Active connective tissue disease such as scleroderma or Crohn's disease • Uncontrolled diabetes mellitus, hypertension or recent cardiovascular disease • Significant neuropathy • Any previous or recent hypersensitivity or contraindication for chemotherapy agents
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response. Timepoint: Before intervention and After surgical resection. Method of measurement: Pathologic examination.;Treatment-related side effects. Timepoint: Weekly measurement from the first week to the end of intervention. Method of measurement: According to the Common Terminology Criteria for Adverse Events (version 4.0). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Mohammadianpanah
Shiraz University of Medical Sciences
Outcome results
None listed