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

NCT01558921 | Active Not Recruiting Phase 3 Results DMC

• 2 other identifiers: NL36315.042.112010-023957-12
• Study Type: interventional
• Target: 920
• Locations: 7 countries
• Sites: 56

Brief 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.

Conditions

Rectal Cancer

Keywords

rectal cancer; radiotherapy; chemotherapy; 5x5; capecitabine; oxaliplatin; CAPOX; FOLFOX; folinic acid; fluorouracil

Outcome Measures

Primary Outcomes (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.

  3 years follow-up after surgery

Secondary Outcomes (9)

• Number of Patients Completing the Prescribe Neo-adjuvant Treatment Dose

  30 days after neoadjuvant treatment

• Number of Patients With Negative CRM Negative

  30 days after surgery

• Number of Patients With a Pathological Complete Response (pCR)

  30 days after surgery

• Number of Patients With Surgical Complications

  30 days after surgery

• Quality of Life QLQ-C30 Scores

  3 year after surgery

Study Arms (2)

B: 5x5Gy -> CAPOX -> surgery

EXPERIMENTAL

experimental group (arm B) M1 scheme: 5 fractions of 5 Gy external beam radiation (5x5Gy) followed by CAPOX followed by TME surgery

Other: M1 scheme

A: 5 weeks chemoradiation -> surgery

ACTIVE COMPARATOR

control group (arm A) standard long course chemoradiotherapy followed by TME surgery

Other: standard long course chemoradiotherapy

Interventions

M1 scheme OTHER

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

B: 5x5Gy -> CAPOX -> surgery

standard long course chemoradiotherapy OTHER

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

A: 5 weeks chemoradiation -> surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Leiden University Medical Center: collaborator
• Uppsala University Hospital: collaborator
• Karolinska University Hospital: collaborator
• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator

Study Sites (56)

Siteman Cancer Center, Washington University Medical School

St Louis, Missouri, 63110, United States

Location

Aalborg Universitetshospital

Aalborg, Denmark

Location

Odense Universitetshospital

Odense, Denmark

Location

University Medical Center Groningen

Groningen, PO BOX 30001, 9700 RB, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location

Amsterdam UMC, location VUMC

Amsterdam, Netherlands

Location

Nki / Avl

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Wilhelmina Ziekenhuis

Assen, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Deventer Hospital

Deventer, Netherlands

Location

Catharina ZIekenhuis

Eindhoven, Netherlands

Location

Het Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Location

de Tjongerschans

Heerenveen, Netherlands

Location

Ziekenhuisgroep Twente

Hengelo, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Radiotherapeutisch Instituut Friesland

Leeuwarden, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Alrijne Ziekenhuis

Leiderdorp, Netherlands

Location

UMC Nijmegen St Radboud

Nijmegen, Netherlands

Location

Antonius Ziekenhuis

Sneek, Netherlands

Location

Bronovo Ziekenhuis

The Hague, Netherlands

Location

HaGaZiekenhuis

The Hague, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Sørlandet Sykehus Kristiansand

Kristiansand, Norway

Location

Oslo Universitetssykehus

Oslo, Norway

Location

Institute of Oncology

Ljubljana, Slovenia

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

ICO Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

Location

Consorcio Hospital General Universitario Valencia

Valencia, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Hospital Universitari i Politècnic la Fe

Valencia, Spain

Location

Södra Älvsborgs Sjukhus

Borås, Sweden

Location

Mälarsjukhuset

Eskilstuna, Sweden

Location

Falu Lasarett

Falun, Sweden

Location

Gävle sjukhus

Gävle, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Kalmar Hospital

Kalmar, Sweden

Location

Centralsjukhuset i Karlstad

Karlstad, Sweden

Location

Linköpings Universitet

Linköping, Sweden

Location

Universitetssjukhuset i Lund

Lund, Sweden

Location

Universitetssjukhuset ÖREBRO

Örebro, Sweden

Location

Skaraborgs Sjukhus

Skövde, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Sundsvalls Sjukhus

Sundsvall, Sweden

Location

Norrlands Universitetssjukhus

Umeå, Sweden

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Centrallasarettet Växjö

Vaxjo, Sweden

Location

Centrallasarett

Västerås, Sweden

Location

Related Publications (25)

• 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.

  PMID: 23742033 BACKGROUND

• 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.

  PMID: 33798955 BACKGROUND

• 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.

  PMID: 35462008 BACKGROUND

• 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.

  PMID: 35568280 BACKGROUND

• 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.

  PMID: 34308767 BACKGROUND

• 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.

  PMID: 33287114 BACKGROUND

• 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.

  PMID: 38192084 BACKGROUND

• 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.

  PMID: 37889954 BACKGROUND

• 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.

  PMID: 40183423 BACKGROUND

• 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.

  PMID: 32240909 RESULT

• 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.

  PMID: 33301740 RESULT

• 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.

  PMID: 35447283 RESULT

• 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.

  PMID: 36581138 RESULT

• 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.

  PMID: 36661037 RESULT

• 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.

  PMID: 36996624 RESULT

• Kus Ozturk S, Graham Martinez C, Sheahan K, Winter DC, Aherne S, Ryan EJ, van de Velde CJ, Marijnen CA, Hospers GA, Roodvoets AG, Doukas M, Mens D, Verhoef C, van der Post RS, Nagtegaal ID. Relevance of shrinkage versus fragmented response patterns in rectal cancer. Histopathology. 2023 Dec;83(6):870-879. doi: 10.1111/his.15027. Epub 2023 Aug 23.

  PMID: 37609761 RESULT

• Zwart WH, Temmink SJD, Hospers GAP, Marijnen CAM, Putter H, Nagtegaal ID, Blomqvist L, Kranenbarg EM, Roodvoets AGH, Martling A, van de Velde CJH, Glimelius B, Peeters KCMJ, van Etten B, Nilsson PJ; Collaborative investigators. Oncological outcomes after a pathological complete response following total neoadjuvant therapy or chemoradiotherapy for high-risk locally advanced rectal cancer in the RAPIDO trial. Eur J Cancer. 2024 Jun;204:114044. doi: 10.1016/j.ejca.2024.114044. Epub 2024 Apr 7.

  PMID: 38636289 RESULT

• Zwart WH, Dijkstra EA, Putter H, Marijnen CAM, Nilsson PJ, van de Velde CJH, van Etten B, Hospers GAP, Glimelius B. Authors' reply-Does the RAPIDO trial suggest a benefit of post-operative chemotherapy after preoperative chemoradiation in rectal cancer? No, it does not. ESMO Open. 2023 Oct;8(5):101645. doi: 10.1016/j.esmoop.2023.101645. Epub 2023 Sep 14. No abstract available.

  PMID: 37713932 RESULT

• Zwart WH, Dijkstra EA, Putter H, Marijnen CAM, Nilsson PJ, van de Velde CJH, van Etten B, Hospers GAP, Glimelius B. Corrigendum to "Authors' reply-Does the RAPIDO trial suggest a benefit of post-operative chemotherapy after preoperative chemoradiation in rectal cancer? No, it does not": [ESMO Open 8 (2023) 101645]. ESMO Open. 2023 Dec;8(6):102042. doi: 10.1016/j.esmoop.2023.102042. Epub 2023 Oct 20. No abstract available.

  PMID: 37866027 RESULT

• Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP. Interpreting the RAPIDO trial: factors to consider - Authors' reply. Lancet Oncol. 2021 Mar;22(3):e90-e91. doi: 10.1016/S1470-2045(21)00087-5. No abstract available.

  PMID: 33662297 RESULT

• Dijkstra EA, Zwart WH, Nilsson PJ, Putter H, Roodvoets AGH, Meershoek-Klein Kranenbarg E, Frodin JE, Nygren P, Ostergaard L, Kersten C, Verbiene I, Cervantes A, Hendriks MP, Capdevila J, Edhemovic I, van de Velde CJH, Marijnen CAM, van Etten B, Hospers GAP, Glimelius B; collaborative investigators. The value of post-operative chemotherapy after chemoradiotherapy in patients with high-risk locally advanced rectal cancer-results from the RAPIDO trial. ESMO Open. 2023 Apr;8(2):101158. doi: 10.1016/j.esmoop.2023.101158. Epub 2023 Mar 3.

  PMID: 36871393 RESULT

• Prata I, Eriksson M, Krdzalic J, Kranenbarg EM, Roodvoets AGH, Beets-Tan R, van de Velde CJH, van Etten B, Hospers GAP, Glimelius B, Nilsson PJ, Marijnen CAM, Peeters KCMJ, Blomqvist LK. Results of a diagnostic imaging audit in a randomised clinical trial in rectal cancer highlight the importance of careful planning and quality control. Insights Imaging. 2023 Nov 24;14(1):206. doi: 10.1186/s13244-023-01552-0.

  PMID: 38001376 RESULT

• Ozturk SK, Bokhorst JM, Baumann E, Sheahan K, van de Velde CJH, Marijnen CAM, Hospers GAP, Doukas M, Vieth M, Lugli A, Nagtegaal ID. Exploring Intratumoral Budding in Colorectal Cancer Using Computational Pathology: A Biopsy-Based Evaluation. Mod Pathol. 2025 Feb;38(2):100655. doi: 10.1016/j.modpat.2024.100655. Epub 2024 Nov 9.

  PMID: 39522647 RESULT

• Zwart WH, Dijkstra EA, Hospers GAP, Marijnen CAM, Putter H, Folkesson J, Van de Velde CJH, Roodvoets AGH, Meershoek-Klein Kranenbarg E, Glimelius B, Van Etten B, Nilsson PJ. Perineal wound complications after total neoadjuvant therapy or chemoradiotherapy followed by abdominoperineal excision in patients with high-risk locally advanced rectal cancer in the RAPIDO trial. BJS Open. 2025 Mar 4;9(2):zraf043. doi: 10.1093/bjsopen/zraf043.

  PMID: 40276906 RESULT

• Tanaka MD, Glimelius B, Hospers GAP, Kranenbarg EM, Marijnen CAM, Putter H, Roodvoets AGH, van de Velde CJH, van Etten B, Nilsson PJ, Couwenberg AM. Acute and Late Radiation-Related Toxicity After Treatment of Locally Advanced Rectal Cancer With Intensity Modulated Radiation Therapy Compared With 3-Dimensional Conformal Radiation Therapy in the RAPIDO Trial. Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):470-482. doi: 10.1016/j.ijrobp.2025.04.035. Epub 2025 May 10.

  PMID: 40354950 RESULT

Related Links

• Dutch Colorectal CancerGroup

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Annet Roodvoets, MSc, project coordinator
• Organization: LUMC

a.g.h.roodvoets@lumc.nl ;clinicalresearchcenter@lumc.nl

+31716253500

Study Officials

• B. van Etten, MD, PhD

  University Medical Center Groningen, Department of Surgery, Groningen, The Netherlands

  PRINCIPAL INVESTIGATOR

• B. Glimelius, MD, PhD

  Akademiska Sjukhuset, Department of Oncology, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

• G. A. Hospers, MD, PhD

  University Medical Center Groningen, Department of Medical Oncology, Groningen, The Netherlands

  PRINCIPAL INVESTIGATOR

• P. Nilsson, MD, PhD

  Karolinska Universitetssjukhuset, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• C. J. van de Velde, MD, PhD

  Leiden University Medical Center, Department of Surgery, Leiden, The Netherlands

  PRINCIPAL INVESTIGATOR

• C.A.M. Marijnen, MD, PhD

  Netherlands Cancer Institute, Amsterdam, the Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. B. van Etten, surgical oncologist

Model Details: standard arm: 5.5 weeks chemoradiation -\> surgery -\> optional chemotherapy experimental arm: 5x5Gy -\> 12 wks chemotherapy -\> surgery

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 20, 2012
• Study Start: June 21, 2011
• Primary Completion: March 8, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Locations

NO (2); SL (1); NL (28); ES (5); SE (17); DK (2); US (1)