Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

Summary

Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy.

Conditions

• Rectal Cancer

Interventions

OTHER

M1 scheme

short course 5x5Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX

OTHER

standard long course chemoradiotherapy

long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Dutch Cancer Society

  collaborator OTHER

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• B. van Etten, MD, PhD · University Medical Center Groningen, Department of Surgery, Groningen, The Netherlands

• B. Glimelius, MD, PhD · Akademiska Sjukhuset, Department of Oncology, Uppsala, Sweden

• G. A. Hospers, MD, PhD · University Medical Center Groningen, Department of Medical Oncology, Groningen, The Netherlands

• P. Nilsson, MD, PhD · Karolinska Universitetssjukhuset, Stockholm, Sweden

• C. J. van de Velde, MD, PhD · Leiden University Medical Center, Department of Surgery, Leiden, The Netherlands

• C.A.M. Marijnen, MD, PhD · Netherlands Cancer Institute, Amsterdam, the Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-21

Primary Completion

2020-03-08

Completion

2026-12-31

Countries

• United States
• Denmark
• Netherlands
• Norway
• Slovenia
• Spain
• Sweden

Study Locations