]>
IRCT201501059979N2 IRCT 2015-02-21 Vice chancellor for research,, Shiraz University of Medical Sciences Study of brachytherapy in rectal cancer Study of efficacy and safety of low-dose rate endorectal brachytherapy in patients with clinical stage T2N1 or T3-4N0-2 resectable low rectal cancer 2014-12-06 anticipated 30 Complete https://irct.ir/trial/10486 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Rectal cancer. 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 included conventional external beam radiotherapy using megavoltage linear accelerator photons. A total dose of 45 Gy external beam radiotherapy will be delivered via a daily fraction of 1.8 Gy, with five fractions per week. Concurrent chemotherapy consisted of oral capecitabine, 825 mg/m2 twice daily during the whole period of the radiotherapy with weekend breaks (Tuesdays and Fridays). All patients will undergo standard surgery 6 weeks after completion of chemoradiation. Pathologic response will be defined through pathologic examination. Treatment-related complications will be determined according to the Common Terminology Criteria for Adverse Events (version 4.0). The endpoints of this study include pathological complete response rate and adverse events (gastrointestinal toxicity)..
public Mohammad Mohammadianpanah
Zand street, Namazi Hospital
Shiraz Iran (Islamic Republic of) 7193613511 +98 71 3612 5168 mohpanah@gmail.com Shiraz University of Medical Sciences scientific Mohammad Mohammadianpanah
Zand street, Namazi Hospital
Shiraz Iran (Islamic Republic of) 7193613511 +98 71 3612 5168 mohpanah@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 90 years Both C20, C21.1 Rectal and anal canal neoplasms Treatment - Other 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 included conventional external beam radiotherapy using megavoltage linear accelerator photons. A total dose of 45 Gy external beam radiotherapy will be delivered via a daily fraction of 1.8 Gy, with five fractions per week. Concurrent chemotherapy consisted of oral capecitabine, 825 mg/m2 twice daily during the whole period of the radiotherapy with weekend breaks (Tuesdays and Fridays). All patients will undergo standard surgery 6 weeks after completion of chemoradiation. Pathologic response will be defined through pathologic examination. Treatment-related complications will be determined according to the Common Terminology Criteria for Adverse Events (version 4.0). The endpoints of this study include pathological complete response rate and adverse events (gastrointestinal toxicity). 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). Vice chancellor for research,, Shiraz University of Medical Sciences Approved 2014-12-06 Medical Research Ethics Committee of Shiraz University of Medical Sciences Medical Research Ethics Committee of Shiraz University of Medical Sciences Shiraz Iran (Islamic Republic of)