NCT01558921: RAPIDO

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

Active, enrolled Phase 3 Last updated 13 January 2023

What this trial tests

Phase 3 trial testing M1 scheme in Rectal Cancer in 920 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 June 2011

Primary endpoint
8 March 2020

31 December 2026

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	920
Start date	21 June 2011
Primary completion	8 March 2020
Estimated completion	31 December 2026
Sites	56 locations across Denmark, Netherlands, Sweden, Norway, Slovenia, United States, Spain

Drugs / interventions tested

• M1 scheme
• standard long course chemoradiotherapy

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial.
   Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, et al · · 2021 · cited 1094× · PMID 33301740 · DOI 10.1016/s1470-2045(20)30555-6
2. Rectal Cancer, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.
   Benson AB, Venook AP, Al-Hawary MM, Cederquist L, et al · · 2018 · cited 648× · PMID 30006429 · DOI 10.6004/jnccn.2018.0061
3. Short-course radiotherapy followed by neo-adjuvant chemotherapy in locally advanced rectal cancer--the RAPIDO trial.
   Nilsson PJ, van Etten B, Hospers GA, Påhlman L, et al · · 2013 · cited 183× · PMID 23742033 · DOI 10.1186/1471-2407-13-279
4. Total Neoadjuvant Therapy (TNT) versus Standard Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: A Systematic Review and Meta-Analysis.
   Liu S, Jiang T, Xiao L, Yang S, et al · · 2021 · cited 162× · PMID 33987952 · DOI 10.1002/onco.13824
5. Total neoadjuvant therapy in locally advanced rectal cancer: Role of systemic chemotherapy.
   Yoo RN, Kim HJ. · · 2019 · cited 33× · PMID 31346574 · DOI 10.1002/ags3.12253
6. Clinical Trial of Oral Nelfinavir before and during Radiation Therapy for Advanced Rectal Cancer.
   Hill EJ, Roberts C, Franklin JM, Enescu M, et al · · 2016 · cited 28× · PMID 26861457 · DOI 10.1158/1078-0432.ccr-15-1489
7. A prospective phase II study of pre-operative chemotherapy then short-course radiotherapy for high risk rectal cancer: COPERNICUS.
   Gollins S, West N, Sebag-Montefiore D, Susnerwala S, et al · · 2018 · cited 26× · PMID 30116024 · DOI 10.1038/s41416-018-0209-4
8. Rectal MRI Interpretation After Neoadjuvant Therapy.
   Horvat N, El Homsi M, Miranda J, Mazaheri Y, et al · · 2023 · cited 25× · PMID 36073323 · DOI 10.1002/jmri.28426