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Short radiation plus chemo before surgery may boost rectal cancer survival

NCT ID NCT01558921

Disease control Sponsor: University Medical Center Groningen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares two treatment approaches for high-risk rectal cancer. The experimental group gets a short course of radiation (5 days) followed by several months of chemotherapy before surgery. The standard group receives longer chemoradiotherapy followed by surgery and optional chemo after. The goal is to see if giving chemo earlier, when patients are stronger, can reduce cancer recurrence and improve survival. About 920 participants are enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
short-course radiation (5x5 Gy) followed by capecitabine and oxaliplatin (CAPOX) chemotherapy
What this could lead to
If successful, this approach could improve survival for people with high-risk rectal cancer by delivering chemotherapy before surgery, when patients are healthier.
What could go wrong
This is a large phase 3 trial, but results are not yet final. The experimental treatment may not improve outcomes over standard care, and chemotherapy side effects can be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

920 people

The number who actually took part.

Started

Jun 2011

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (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+) 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 Dihydro-Pyrimidine Dehydrogenase (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

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

Contacts and locations

Locations

  • Aalborg Universitetshospital

    Aalborg, Denmark

  • Akademiska Sjukhuset

    Uppsala, Sweden

  • Alrijne Ziekenhuis

    Leiderdorp, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Amsterdam UMC, location AMC

    Amsterdam, Netherlands

  • Amsterdam UMC, location VUMC

    Amsterdam, Netherlands

  • Antonius Ziekenhuis

    Sneek, Netherlands

  • Bronovo Ziekenhuis

    The Hague, Netherlands

  • Catharina ZIekenhuis

    Eindhoven, Netherlands

  • Centrallasarett

    Västerås, Sweden

  • Centrallasarettet Växjö

    Vaxjo, Sweden

  • Centralsjukhuset i Karlstad

    Karlstad, Sweden

  • Consorcio Hospital General Universitario Valencia

    Valencia, Spain

  • Deventer Hospital

    Deventer, Netherlands

  • Diakonessenhuis

    Utrecht, Netherlands

  • Falu Lasarett

    Falun, Sweden

  • Gävle sjukhus

    Gävle, Sweden

  • HaGaZiekenhuis

    The Hague, Netherlands

  • Het Groene Hart Ziekenhuis

    Gouda, Netherlands

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital Universitari i Politècnic la Fe

    Valencia, Spain

  • Hospital Vall d'Hebron

    Barcelona, Spain

  • ICO Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Spain

  • Institute of Oncology

    Ljubljana, Slovenia

  • Isala Klinieken

    Zwolle, Netherlands

  • Kalmar Hospital

    Kalmar, Sweden

  • Karolinska Universitetssjukhuset

    Stockholm, Sweden

  • Leiden University Medical Center

    Leiden, Netherlands

  • Linköpings Universitet

    Linköping, Sweden

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Medisch Centrum Haaglanden

    The Hague, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Mälarsjukhuset

    Eskilstuna, Sweden

  • Nki / Avl

    Amsterdam, Netherlands

  • Noordwest Ziekenhuisgroep

    Alkmaar, Netherlands

  • Norrlands Universitetssjukhus

    Umeå, Sweden

  • Odense Universitetshospital

    Odense, Denmark

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, Netherlands

  • Oslo Universitetssykehus

    Oslo, Norway

  • Radiotherapeutisch Instituut Friesland

    Leeuwarden, Netherlands

  • Reinier de Graaf Groep

    Delft, Netherlands

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Sweden

  • Siteman Cancer Center, Washington University Medical School

    St Louis, Missouri, 63110, United States

  • Skaraborgs Sjukhus

    Skövde, Sweden

  • Spaarne Ziekenhuis

    Hoofddorp, Netherlands

  • Sundsvalls Sjukhus

    Sundsvall, Sweden

  • Södra Älvsborgs Sjukhus

    Borås, Sweden

  • Sørlandet Sykehus Kristiansand

    Kristiansand, Norway

  • UMC Nijmegen St Radboud

    Nijmegen, Netherlands

  • Universitair Medisch Centrum Groningen

    Groningen, Netherlands

  • Universitetssjukhuset i Lund

    Lund, Sweden

  • Universitetssjukhuset ÖREBRO

    Örebro, Sweden

  • University Medical Center Groningen

    Groningen, PO BOX 30001, 9700 RB, Netherlands

  • Wilhelmina Ziekenhuis

    Assen, Netherlands

  • Ziekenhuisgroep Twente

    Hengelo, Netherlands

  • de Tjongerschans

    Heerenveen, Netherlands

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