Radiation Dose Escalation in Locally Advanced Rectal Cancer
NCT ID: NCT02603302
Last Updated: 2016-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2016-01-31
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers
NCT03200249
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
NCT05622357
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
NCT04664504
Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
NCT04674696
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
NCT05807984
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Locally advanced rectal cancer
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.
Dose Escalation Radiotherapy
RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU
Delayed surgery
Surgery after 8 weeks with TME (total mesorectal excision)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dose Escalation Radiotherapy
RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU
Delayed surgery
Surgery after 8 weeks with TME (total mesorectal excision)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Brasilia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marcos Santos
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcos Santos, MD PhD
Role: STUDY_CHAIR
Brasília University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brasilia Univeristy Hospital
Brasília, Federal District, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.