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 (RAPIDO study)

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 (RAPIDO study) - RAPIDO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47895

Enrollment

361

Registered

2011-04-26

Start date

2012-03-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

Standard or experimental treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Biopsy-proven, newly diagnosed primary rectal adenocarcinoma. • Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically: o Clinical stage (c) T4a o cT4b o EMVI+ o N2 o Positive MRF, i.e. tumour = 18 years. • ECOG Performance Status of 0 - 1.

Exclusion criteria

Exclusion criteria: • Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots. • 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. • Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
disease related treatment failure.	—

Secondary

Measure	Time frame
Overall survival, CRM negative (margin > 1 mm) rate, Pathological complete response (pCR) rate, Short and long-term toxicity, Surgical complications, Quality of life. Pharmacogenomics.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)