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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional fraction

Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily

Group Type ACTIVE_COMPARATOR

conventional fraction

Intervention Type RADIATION

capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f

SIB

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

Group Type EXPERIMENTAL

SIB

Intervention Type RADIATION

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

Interventions

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conventional fraction

capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f

Intervention Type RADIATION

SIB

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

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No