Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Study Overview
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Brief Summary
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Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

Official Title
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Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Radiation: conventional fraction
* Radiation: SIB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound Exclusion Criteria: metastatic disease Eastern Cooperative Oncology Group (ECOG) performance status > 3 patients not deemed fit for radiotherapy, capecitabine or surgery pregnant or lactating patients women with child bearing potential who lack effective contraception patients below 18 years old

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional fraction<br>Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily | Radiation: conventional fraction<br>* capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f<br>|
| Experimental: SIB<br>Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily | Radiation: SIB<br>* Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Pathological complete remission rate (pCR) |  | after pathological examination of surgical speciments (6-8 weeks after chemoradiation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | during preoperative treatment and after surgery for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Chemoradiotherapy, Locally Advanced Rectal Cancer, boost, IMRT