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ACTIVE NOT RECRUITING

NCT01558921

PHASE3

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

920

Start Date

2011-06-21

Completion Date

2026-12-31

Last Updated

2023-01-13

Healthy Volunteers

Conditions

Rectal Cancer

Interventions

OTHER

M1 scheme

short course 5 x 5 Gy 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.

Inclusion Criteria: Primary tumour characteristics: 1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum 2. Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically (T4a, i.e. overgrowth to an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side wall (according to TNM version 5), cT4b, i.e. peritoneal involvement, extramural vascular invasion (EMVI+). N2, i.e. four or more lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. Positive MRF, i.e. tumor or lymph node \< 1 mm from the mesorectal fascia. Enlarged lateral nodes, \> 1 cm (lat LN+) Exclusion Criteria: 1. 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 2. Presence of metastatic disease or recurrent rectal tumour 3. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn¡¦s disease or active ulcerative Colitis 4. 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 5. Known DPD deficiency 6. Any contraindications to MRI (e.g. patients with pacemakers) 7. Medical or psychiatric conditions that compromise the patient's ability to give informed consent 8. Concurrent uncontrolled medical conditions 9. Any investigational treatment for rectal cancer within the past month 10. Pregnancy or breast feeding 11. Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract 12. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months 13. Patients with symptoms or history of peripheral neuropathy

Locations (56)

Siteman Cancer Center, Washington University Medical School

St Louis, Missouri, United States

Aalborg Universitetshospital

Aalborg, Denmark

Odense Universitetshospital

Odense, Denmark

University Medical Center Groningen

Groningen, PO BOX 30001, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Amsterdam UMC, location VUMC

Amsterdam, Netherlands

Nki / Avl

Amsterdam, Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Wilhelmina Ziekenhuis

Assen, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Reinier de Graaf Groep

Delft, Netherlands

Deventer Hospital

Deventer, Netherlands

Catharina ZIekenhuis

Eindhoven, Netherlands

Het Groene Hart Ziekenhuis

Gouda, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

de Tjongerschans

Heerenveen, Netherlands

Ziekenhuisgroep Twente

Hengelo, Netherlands

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Radiotherapeutisch Instituut Friesland

Leeuwarden, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Alrijne Ziekenhuis

Leiderdorp, Netherlands

UMC Nijmegen St Radboud

Nijmegen, Netherlands

Antonius Ziekenhuis

Sneek, Netherlands

Bronovo Ziekenhuis

The Hague, Netherlands

HaGaZiekenhuis

The Hague, Netherlands

Medisch Centrum Haaglanden

The Hague, Netherlands

Diakonessenhuis

Utrecht, Netherlands

Isala Klinieken

Zwolle, Netherlands

Sørlandet Sykehus Kristiansand

Kristiansand, Norway

Oslo Universitetssykehus

Oslo, Norway

Institute of Oncology

Ljubljana, Slovenia

Hospital Vall d'Hebron

Barcelona, Spain

ICO Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

Consorcio Hospital General Universitario Valencia

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politècnic la Fe

Valencia, Spain

Södra Älvsborgs Sjukhus

Borås, Sweden

Mälarsjukhuset

Eskilstuna, Sweden

Falu Lasarett

Falun, Sweden

Gävle sjukhus

Gävle, Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Kalmar Hospital

Kalmar, Sweden

Centralsjukhuset i Karlstad

Karlstad, Sweden

Linköpings Universitet

Linköping, Sweden

Universitetssjukhuset i Lund

Lund, Sweden

Universitetssjukhuset ÖREBRO

Örebro, Sweden

Skaraborgs Sjukhus

Skövde, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Sundsvalls Sjukhus

Sundsvall, Sweden

Norrlands Universitetssjukhus

Umeå, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Centrallasarettet Växjö

Vaxjo, Sweden

Centrallasarett

Västerås, Sweden

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)