RAPIDO: Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy

Trial Overview

Acronym	RAPIDO
Number	NCT01558921
Protocol Link	https://clinicaltrials.gov/ct2/show/NCT01558921
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT01558921
Status	Open/recruiting
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Neoadjuvant

Trial Description

Short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery and optional adjuvant chemotherapy.

Chief Investigator

B. van Etten
MD, PhD

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Lead Centre

University Medical Center Groningen
Hanzeplein 1
GZ Groningen
9713
Netherlands

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Collaboration and Funding

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Objective:	The study compares two different preoperative regimens for locally advanced rectal cancer. The primary outcome measure is DFS after 3 years. Secondary objectives are to describe the toxicity profile, the rate of completion of preoperative treatment, the fraction of patients with a radical resection (R0) and to determine the rate of pathological complete response (pCR). Furthermore, local recurrence rate after 3 years follow-up, quality of life (QoL), functional outcome and overall survival (OS) are secondary endpoints.
Aim:	.
Methods:	Patients will be randomized between an experimental group (arm B) in which short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine/5FU and oxaliplatin) and surgery and a control group (arm A) with long course chemoradiotherapy followed by surgery. In arm A adjuvant chemotherapy is allowed according to the local protocol of the institution. In both groups the rectal tumour will be removed by TME surgery or more extensive surgery if required because of tumour extent.
Reason for International Trial:	.

Trial Details

RAPIDO: Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy

Trial Overview

Trial Description

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Lead Centre

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Additional Information

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Trial Details

RAPIDO: Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

Why join us?

Members

Research

Education

News & Events

About ESCP

Contact Us

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