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Rectal CancerPhase 3RAPIDONCT01558921

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

A Phase 3 study testing M1 scheme and standard long course chemoradiotherapy in people with Rectal Cancer, run by University Medical Center Groningen at 56 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
M1 scheme and standard long course chemoradiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
56 sitesin 7 countries
Study dates
21 Jun 2011to 31 Dec 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary tumour characteristics:
  • Histological proof of newly diagnosed primary adenocarcinoma of the rectum
  • Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically (clinical T4a, i.e. overgrowth to an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side wall (according to tumor node metastasis (TNM-Classification version 5)), clinical T4b, 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 Mesorectal Fascia (MRF+), i.e. tumor or lymph node < 1 mm from the mesorectal fascia. Enlarged lateral nodes (LN), > 1 cm (lat LN+)

Who cannot join

  • 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)
Show all 13Show fewer
  • 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
  • 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
  • Patients with symptoms or history of peripheral neuropathy

Trial locations and contacts

56 sites in 7 countries.

56 sites in 7 countries

Netherlands28 sites

  • 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

  • University Medical Center Groningen

    Groningen, PO BOX 30001, 9700 RB

  • 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

  • Antonius Ziekenhuis

    Sneek

  • Bronovo Ziekenhuis

    The Hague

  • HaGaZiekenhuis

    The Hague

  • Medisch Centrum Haaglanden

    The Hague

  • Diakonessenhuis

    Utrecht

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

Sweden17 sites

  • Södra Älvsborgs Sjukhus

    Borås

  • Mälarsjukhuset

    Eskilstuna

  • Falu Lasarett

    Falun

  • Gävle sjukhus

    Gävle

  • Sahlgrenska Universitetssjukhuset

    Gothenburg

  • Kalmar Hospital

    Kalmar

  • Centralsjukhuset i Karlstad

    Karlstad

  • Linköpings Universitet

    Linköping

  • Universitetssjukhuset i Lund

    Lund

  • Universitetssjukhuset ÖREBRO

    Örebro

  • Skaraborgs Sjukhus

    Skövde

  • Karolinska Universitetssjukhuset

    Stockholm

  • Sundsvalls Sjukhus

    Sundsvall

  • Norrlands Universitetssjukhus

    Umeå

  • Akademiska Sjukhuset

    Uppsala

  • Centrallasarett

    Västerås

  • Centrallasarettet Växjö

    Vaxjo

Other trials in Sweden

Spain5 sites

  • Hospital Vall d'Hebron

    Barcelona

  • ICO Hospital Duran I Reynals

    L'Hospitalet de Llobregat

  • Consorcio Hospital General Universitario Valencia

    Valencia

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Universitari i Politècnic la Fe

    Valencia

Other trials in Spain

Denmark2 sites

  • Aalborg Universitetshospital

    Aalborg

  • Odense Universitetshospital

    Odense

Other trials in Denmark

Norway2 sites

  • Sørlandet Sykehus Kristiansand

    Kristiansand

  • Oslo Universitetssykehus

    Oslo

Other trials in Norway

United States1 site

  • Siteman Cancer Center, Washington University Medical School

    St Louis, Missouri, 63110

Other trials in United States

Slovenia1 site

  • Institute of Oncology

    Ljubljana

Other trials in Slovenia

About this study

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.

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.

Read the detailed description

Patients will be randomized between an experimental group (arm B) in which short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine/ 5-fluorouracil and oxaliplatin) and surgery and a control group (arm A) with long course chemoradiotherapy followed by surgery. In arm A adjuvant chemotherapy is allowed according to the local protocol of the institution. In both groups the rectal tumour will be removed by TME surgery or more extensive surgery if required because of tumour extent.

Conditions
Rectal Cancer
Being tested
M1 scheme, standard long course chemoradiotherapy
Keywords
rectal cancer, radiotherapy, chemotherapy, 5x5, capecitabine, oxaliplatin, CAPOX, FOLFOX, folinic acid, fluorouracil
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M1 schemeOther

    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

  • standard long course chemoradiotherapyOther

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

Study groups in NCT01558921
Study groupRoleWhat they receive
B: 5x5Gy -> CAPOX -> surgeryExperimentalexperimental group (arm B) M1 scheme: 5 fractions of 5 Gy external beam radiation (5x5Gy) followed by CAPOX followed by TME surgery
Receives: Other: M1 scheme
A: 5 weeks chemoradiation -> surgeryActive comparatorcontrol group (arm A) standard long course chemoradiotherapy followed by TME surgery
Receives: Other: standard long course chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Disease Related Treatment Failure (DrTF)

    DrTF = Either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. In case of local regrowth after wait \& watch strategy, followed by no resection or R2 resection, diagnosis local regrowth is taken. Patients lost to follow-up will be censored the last date of patient visit. Survival curves for Disease related Treatment Failure after 3 years of follow-up will be constructed using the method of Kaplan and Meier.

    Measured: 3 years follow-up after surgery

Secondary outcomes (9)

  1. Number of Patients Completing the Prescribe Neo-adjuvant Treatment Dose

    Number of patients in the experimental arm receiving 5 fractions of x 5 Gy (5x5Gy) radiotherapy followed by at least 75% of the prescribed chemotherapy.

    In the standard arm receiving the prescribed chemoradiotherapy.

    Measured: 30 days after neoadjuvant treatment

  2. Number of Patients With Negative CRM Negative

    Number of patients with a Circumferential Resection Margin (CRM) > 1 mm

    Measured: 30 days after surgery

  3. Number of Patients With a Pathological Complete Response (pCR)

    Number of patients with a Pathological Complete Response (pCR) after neo-adjuvant treatment

    Measured: 30 days after surgery

  4. Number of Patients With Surgical Complications

    Number of patients with surgical complications: wound rupture, bleeding, infection, rectal anastomotic leak

    Measured: 30 days after surgery

  5. Quality of Life QLQ-C30 Scores

    Quality of life QLQ-C30 core questionnaire EORTC quality-of-life instrument for use in international clinical trials in oncology A total Quality of Life Questionnaire (QLQ) score can range from 0 to 88, higher score means worse outcome.

    Measured: 3 year after surgery

  6. Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-QLQ-CIPN20)

    Quality of life EORTC-QLQ-CIPN20. International EORTC questionnaire to assess Chemotherapy-Induced Peripheral Neuropathy (CIPN).

    A total QLQ-CIPN20 score can range from 0 to 100, higher score means worse outcome. Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and compromised quality of life.

    Measured: 3 year after surgery

  7. Quality of Life LARS Scores

    Low Anterior Resection Syndrome (LARS) scores in patients without a stoma three years after curative surgery Patient reported score (5 questions). 0-12 no LARS, 21-29 Minor LARS, 30-42 Major LARS.

    Higher scores mean a worse outcome.

    Measured: 3 year after surgery

  8. Number of Patients With a Locoregional Recurrence

    Number of patients with a locoregional recurrence (LRR) after an R0/R1 resection

    Measured: 5 years after surgery

  9. Overall Survival

    Overall survival will be computed as the time between randomization and colorectal cancer or treatment related death. Patients lost to follow-up will be censored the last date of patient visit.

    In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour.

    Measured: 10 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2012 (estimated)
  2. Study start21 Jun 2011
  3. Primary completion8 Mar 2020
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
standard arm: 5.5 weeks chemoradiation -\> surgery -\> optional chemotherapy experimental arm: 5x5Gy -\> 12 wks chemotherapy -\> surgery
Masking
None (open label)
Enrolment
920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558921
Sponsor's protocol ID
NL36315.042.11
Other IDs
2010-023957-12
Acronym
RAPIDO
Status last verified
Apr 2026
First submitted
18 Mar 2012
Last updated
1 May 2026
Data monitoring committee
Yes

Publications

  • Nilsson PJ, van Etten B, Hospers GA, Pahlman L, van de Velde CJ, Beets-Tan RG, Blomqvist L, Beukema JC, Kapiteijn E, Marijnen CA, Nagtegaal ID, Wiggers T, Glimelius B. Short-course radiotherapy followed by neo-adjuvant chemotherapy in locally advanced rectal cancer--the RAPIDO trial. BMC Cancer. 2013 Jun 7;13:279. doi: 10.1186/1471-2407-13-279.

    PubMed 23742033

  • Giunta EF, Bregni G, Pretta A, Deleporte A, Liberale G, Bali AM, Moretti L, Troiani T, Ciardiello F, Hendlisz A, Sclafani F. Total neoadjuvant therapy for rectal cancer: Making sense of the results from the RAPIDO and PRODIGE 23 trials. Cancer Treat Rev. 2021 May;96:102177. doi: 10.1016/j.ctrv.2021.102177. Epub 2021 Mar 16.

    PubMed 33798955

  • Jimenez-Fonseca P, Salazar R, Valenti V, Msaouel P, Carmona-Bayonas A. Is short-course radiotherapy and total neoadjuvant therapy the new standard of care in locally advanced rectal cancer? A sensitivity analysis of the RAPIDO clinical trial. Ann Oncol. 2022 Aug;33(8):786-793. doi: 10.1016/j.annonc.2022.04.010. Epub 2022 Apr 22.

    PubMed 35462008

  • Glynne-Jones R, Harrison M. Should the RAPIDO schedule represent standard of care in locally advanced rectal cancer? Ann Oncol. 2022 Aug;33(8):745-746. doi: 10.1016/j.annonc.2022.05.002. Epub 2022 May 12. No abstract available.

    PubMed 35568280

  • Patel A, Spychalski P, Corrao G, Jereczek-Fossa BA, Glynne-Jones R, Garcia-Aguilar J, Kobiela J. Neoadjuvant short-course radiotherapy with consolidation chemotherapy for locally advanced rectal cancer: a systematic review and meta-analysis. Acta Oncol. 2021 Oct;60(10):1308-1316. doi: 10.1080/0284186X.2021.1953137. Epub 2021 Jul 24.

    PubMed 34308767

  • Papaccio F, Rosello S, Huerta M, Gambardella V, Tarazona N, Fleitas T, Roda D, Cervantes A. Neoadjuvant Chemotherapy in Locally Advanced Rectal Cancer. Cancers (Basel). 2020 Dec 3;12(12):3611. doi: 10.3390/cancers12123611.

    PubMed 33287114

  • Ozturk SK, Martinez CG, Mens D, Verhoef C, Tosetto M, Sheahan K, de Wilt JHW, Hospers GAP, van de Velde CJH, Marijnen CAM, van der Post RS, Nagtegaal ID. Lymph node regression after neoadjuvant chemoradiotherapy in rectal cancer. Histopathology. 2024 May;84(6):935-946. doi: 10.1111/his.15134. Epub 2024 Jan 8.

    PubMed 38192084

  • Nilsson PJ, van Etten B, Hospers GAP, Marijnen CAM, Meershoek-Klein Kranenberg E, Roodvoets AGH, van de Velde CJH, Glimelius B. Comment on the RAPIDO Trial Point-Counterpoint Debate. Dis Colon Rectum. 2024 Feb 1;67(2):e126. doi: 10.1097/DCR.0000000000003138. Epub 2023 Oct 26. No abstract available.

    PubMed 37889954

  • Polack M, van Pelt GW, van den Heuvel DH, Klein-Kranenbarg EM, Roodvoets AGH, Putter H, Crobach ASLP, Nagtegaal ID, Peeters KCMJ, Tollenaar RAEM, van Krieken JHJM, Mesker WE. The tumour-stroma ratio as predictive aid towards a biopsy-based treatment strategy in rectal carcinoma. Histopathology. 2025 Jul;87(1):44-57. doi: 10.1111/his.15423. Epub 2025 Apr 4.

    PubMed 40183423

  • van der Valk MJM, Marijnen CAM, van Etten B, Dijkstra EA, Hilling DE, Kranenbarg EM, Putter H, Roodvoets AGH, Bahadoer RR, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes AMR, de Groot DJA, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; Collaborative investigators. Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial. Radiother Oncol. 2020 Jun;147:75-83. doi: 10.1016/j.radonc.2020.03.011. Epub 2020 Mar 30.

    PubMed 32240909

  • Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. 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. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.

    PubMed 33301740

  • Dijkstra EA, Hospers GAP, Kranenbarg EM, Fleer J, Roodvoets AGH, Bahadoer RR, Guren MG, Tjalma JJJ, Putter H, Crolla RMPH, Hendriks MP, Capdevila J, Radu C, van de Velde CJH, Nilsson PJ, Glimelius B, van Etten B, Marijnen CAM. Quality of life and late toxicity after short-course radiotherapy followed by chemotherapy or chemoradiotherapy for locally advanced rectal cancer - The RAPIDO trial. Radiother Oncol. 2022 Jun;171:69-76. doi: 10.1016/j.radonc.2022.04.013. Epub 2022 Apr 18.

    PubMed 35447283

  • Dijkstra EA, Zwart WH, Putter H, Marijnen CAM, Nilsson PJ, van de Velde CJH, van Etten B, Hospers GAP, Glimelius B. Authors' reply-A sensitivity analysis of the RAPIDO clinical trial. Ann Oncol. 2023 Apr;34(4):446-447. doi: 10.1016/j.annonc.2022.12.012. Epub 2022 Dec 26. No abstract available.

    PubMed 36581138

  • Dijkstra EA, Nilsson PJ, Hospers GAP, Bahadoer RR, Meershoek-Klein Kranenbarg E, Roodvoets AGH, Putter H, Berglund A, Cervantes A, Crolla RMPH, Hendriks MP, Capdevila J, Edhemovic I, Marijnen CAM, van de Velde CJH, Glimelius B, van Etten B; Collaborative Investigators. Locoregional Failure During and After Short-course Radiotherapy Followed by Chemotherapy and Surgery Compared With Long-course Chemoradiotherapy and Surgery: A 5-Year Follow-up of the RAPIDO Trial. Ann Surg. 2023 Oct 1;278(4):e766-e772. doi: 10.1097/SLA.0000000000005799. Epub 2023 Jan 20.

    PubMed 36661037

  • Bahadoer RR, Hospers GAP, Marijnen CAM, Peeters KCMJ, Putter H, Dijkstra EA, Kranenbarg EM, Roodvoets AGH, van Etten B, Nilsson PJ, Glimelius B, van de Velde CJH; collaborative investigators. Risk and location of distant metastases in patients with locally advanced rectal cancer after total neoadjuvant treatment or chemoradiotherapy in the RAPIDO trial. Eur J Cancer. 2023 May;185:139-149. doi: 10.1016/j.ejca.2023.02.027. Epub 2023 Mar 7.

    PubMed 36996624

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing M1 scheme and standard long course chemoradiotherapy in people with Rectal Cancer, run by University Medical Center Groningen at 56 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Netherlands, Sweden, Spain, Denmark, Norway and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Disease Related Treatment Failure (DrTF) (time frame: 3 years follow-up after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01558921, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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