A Phase 2 interventional study of Dose Escalation Radiotherapy and Delayed surgery in Rectal Cancer, sponsored by University of Brasilia. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-14.
Sponsored by University of Brasilia · Phase 2, Interventional, and Treatment
This is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete response).
Introduction:
Rectal cancer is a highly prevalent disease all over the world. In Brazil, it is the second most common cancer among women (after breast tumors), with an estimated incidence of 17.2 cases per 100,000 inhabitants and is the third most common cancer in men (after prostate and lung cancers), with an estimated incidence of 15.4 cases per 100,000 inhabitants.
Goals:
The aim of this study is to evaluate the pathologic complete response (pCR) of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant radiochemotherapy (RCT) employing anticancer drugs at standard dose and interval extended to surgery with or without adjuvant neoplastic therapy.
Procedures:
Neoadjuvant chemoradiotherapy with radiation dose escalation associated with radiosensitizing therapy and surgery with a total mesorectal excision (TME), 8 weeks after completing neoadjuvant treatment.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 48 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →University of Brasilia is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV + Chemotherapy with 5-FU Surgery 8 weeks after the neoadjvuant treatment.
Radiation: Dose Escalation Radiotherapy · Procedure: Delayed surgery
RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU
Surgery after 8 weeks with TME (total mesorectal excision)
Pathologic complete response
Pathologic evaluation of the surgical specimen
Time frame: Through study completion, an average of 2 years
Disease free survival
Evaluation of disease free survival
Time frame: 2 years
Overall survival
Evaluation of overall survival
Time frame: 2 years
Plan to share: Yes — We may share data in requested by metanalists
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Brasilia