Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial (NCT01558921)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (14 items).
Location: Siteman Cancer Center, Washington University Medical School — St Louis, Missouri
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen
- Presence of metastatic disease or recurrent rectal tumour
- Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis
- Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
- Known Dihydro-Pyrimidine Dehydrogenase (DPD) deficiency
- Any contraindications to MRI (e.g. patients with pacemakers)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Concurrent uncontrolled medical conditions
- Any investigational treatment for rectal cancer within the past month
- Pregnancy or breast feeding
- Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (56 Sites)
- Siteman Cancer Center, Washington University Medical School — St Louis, Missouri
- Aalborg Universitetshospital — Aalborg,
- Odense Universitetshospital — Odense,
- University Medical Center Groningen — Groningen, PO BOX 30001
- Noordwest Ziekenhuisgroep — Alkmaar,
- Amsterdam UMC, location AMC — Amsterdam,
- Amsterdam UMC, location VUMC — Amsterdam,
- Nki / Avl — Amsterdam,
- Onze Lieve Vrouwe Gasthuis — Amsterdam,
- Wilhelmina Ziekenhuis — Assen,
- Amphia Ziekenhuis — Breda,
- Reinier de Graaf Groep — Delft,
- Deventer Hospital — Deventer,
- Catharina ZIekenhuis — Eindhoven,
- Het Groene Hart Ziekenhuis — Gouda,
- Martini Ziekenhuis — Groningen,
- Universitair Medisch Centrum Groningen — Groningen,
- de Tjongerschans — Heerenveen,
- Ziekenhuisgroep Twente — Hengelo,
- Spaarne Ziekenhuis — Hoofddorp,
- Medisch Centrum Leeuwarden — Leeuwarden,
- Radiotherapeutisch Instituut Friesland — Leeuwarden,
- Leiden University Medical Center — Leiden,
- Alrijne Ziekenhuis — Leiderdorp,
- UMC Nijmegen St Radboud — Nijmegen,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.