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Radiation Dose Escalation in Locally Advanced Rectal Cancer

Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced Rectal Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02603302
Acronym
RaDE
Enrollment
48
Registered
2015-11-11
Start date
2016-01-31
Completion date
2018-12-31
Last updated
2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer, radiotherapy, escalated dose, interval

Brief summary

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).

Detailed description

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.

Interventions

RADIATIONDose Escalation Radiotherapy

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)

Sponsors

University of Brasilia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+

Exclusion criteria

* Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor

Design outcomes

Primary

MeasureTime frameDescription
Pathologic complete responseThrough study completion, an average of 2 yearsPathologic evaluation of the surgical specimen

Secondary

MeasureTime frameDescription
Disease free survival2 yearsEvaluation of disease free survival
Overall survival2 yearsEvaluation of overall survival

Countries

Brazil

Contacts

Primary ContactMarcos Santos, MD PhD
marcosrxt@gmail.com+ 55 61 83554308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026