Radiation Dose Escalation in Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Radiation: Dose Escalation Radiotherapy
* Procedure: Delayed surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Locally advanced rectal cancer<br>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<br>* RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU<br>Procedure: Delayed surgery<br>* Surgery after 8 weeks with TME (total mesorectal excision)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response | Pathologic evaluation of the surgical specimen | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Evaluation of disease free survival | 2 years | 
| Overall survival | Evaluation of overall survival | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, radiotherapy, escalated dose, interval