DETECT: Target Volume for Rectal Endoluminal Radiation Boosting

An observational study of Rectal Cancer, run by Maastricht Radiation Oncology at 3 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The aim of the study is to provide prospective data regarding microscopic tumor spread in all directions from the macroscopic tumor in pathology specimens, as seen by eye, and on imaging to define the target volume for endoluminal radiation boosting in rectal cancer patients. 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?: Ultrasound, Rectoscopy and Scan, e.g. CT (resection specimen)
How many people: 50 participants
Where: 3 sitesNetherlands
Study dates: 16 Aug 2022to Dec 2027
Phase: Observational
Are there results?: Not yet: the study is under way

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

Study population: Patients with a limited (ycT1-3N0) residual tumor after neoadjuvant radiotherapy or long-course chemoradiotherapy for rectal adenocarcinoma.

Who may be able to join

≥18 years of age and capable of giving informed consent.
ycT1-3N0(*) residual(**) histology confirmed rectal adenocarcinoma after neoadjuvant radiotherapy or long-course chemoradiotherapy for which patients will undergo TME surgery.
Minimal interval between end of neoadjuvant chemoradiotherapy or radiotherapy: 6 weeks.
()= as determined by clinical assessment (digital rectal examination, endoscopy with or without biopsy) and/or MRI. Biopsy/histology around the time of diagnosis is adequate; no biopsy/histology is needed after neoadjuvant therapy.
()= including tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These patients will also be included after the local recurrence has been determined using endoscopy and/or MRI.

Who cannot join

Patient has received brachytherapy as part of neoadjuvant treatment.
<18 years of age or incapable of giving informed consent.
Patient has not been treated with neoadjuvant radiotherapy or long-course chemoradiotherapy.
Patient will not undergo TME surgery for a ycT1-3N0 residual histology confirmed rectal adenocarcinoma.
Interval between end of neoadjuvant therapy and surgery is <6 weeks.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maaike Berbée, MD, PhD contact

0031884455600

maaike.berbee@maastro.nl

Evert Van Limbergen, MD, PhD contact

0031884455600

evert.vanlimbergen@maastro.nl

Netherlands3 sites, 3 recruiting

Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
An-Sofie Verrijssen, MD, 0031402396400
Pim Burger, MD, PhD, 0031402396600
Recruiting
Maastro
Maastricht, Limburg, 6229 ET
Maaike Berbée, MD, PhD, 0031884455600
Evert Van Limbergen, MD, PhD, 0031884455600
Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Maaike Berbée, MD, PhD, 0031884455600
Jarno Melenhorst, MD, PhD, 0031433874900
Recruiting

Other trials in Netherlands

About this study

Official title: DETECT: Defining the Target Volume for Endoluminal Radiation Boosting in Patients With Rectal Cancer

Read the detailed description

This study is a prospective multicentre cohort trial in ≥50 patients with a residual ycT1-3N0 tumor after neoadjuvant chemoradiotherapy or radiotherapy for rectal adenocarcinoma at least 6 weeks after the neoadjuvant treatment.

In addition to standard workup and treatment (e.g. a flexible endoscopy and an MRI scan at 6-8 weeks post-neoadjuvant therapy), patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these procedures are not already part of standard workup. Furthermore, the pathological specimens of some patients will be scanned using MR imaging during certain parts of the pathological process.

Objectives include determining the maximum distance of microscopic tumor spread per patient in all directions, creating a tissue deformation model to account for changes due to e.g. fixation and pathological processing, using this tissue deformation model to translate the microscopic tumor spread back to the in vivo situation (e.g. back to in vivo MRI scans, 3D endo-ultrasounds), and evaluating/determining risk factors for the presence and/or extent of microscopic tumor spread.

This data will be used for target volume definition in rectal endoluminal radiation boosting.

Conditions: Rectal Cancer
Being tested: Ultrasound, Rectoscopy, Scan, e.g. CT (resection specimen)
Keywords: Rectal Cancer, Microscopic Tumor Spread, Target Volume Definition, Endoluminal Radiation Boosting
Medical subject headings: Rectal Neoplasms

What participants receive

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

UltrasoundDiagnostic test
3D endorectal ultrasound.
RectoscopyDiagnostic test
Rigid rectoscopy.
Scan, e.g. CT (resection specimen)Other
For some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.

Study groups in NCT04927897
Study group	Role	What they receive
Observational		In addition to standard workup and treatment, patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these are not part of standard workup yet. Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Rectoscopy; Other: Scan, e.g. CT (resection specimen)

What is being measured

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

Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen
The maximum distance of microscopic tumor spread in all directions from the macroscopic remnant in the specimen will be measured per patient in millimeters by the pathology department in the pathologic resection specimens.
Measured: During post-resection pathological analysis (i.e. approximately 14 days post-resection)

Secondary outcomes (8)

Maximum distance of microscopic tumor spread per patient from the macroscopic tumor remnant in the pathology specimen, reported separately for MTS perpendicular to the bowel wall and for MTS parallel to the bowel wall
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. Microscopic tumor spread perpendicular to the bowel wall and parallel to the bowel wall will be reported separately.
Measured: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen excluding ypT0 patients
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported excluding all ypT0 patients.
Measured: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only including patients with microscopic tumor spread
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with microscopic tumor spread.
Measured: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only for patients with regrowths
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with regrowths.
Measured: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Tissue deformation factor/model to compensate for tissue deformation due to removal of the specimen from the body, formalin fixation and tissue processing at the pathology department
The deidentified images of the flexible endoscopy and in vivo MRI scan will be collected for the study. During the certain parts of the pathologic process, e.g. before and after fixation, MRIs of the pathological specimens of some of the patients will be made. These deidentified images of the specimens, together with e.g. the deidentified endoscopic, rectoscopic, ultrasound and in vivo MR images and possibly with optical images taken during pathological analysis, will be used to develop the deformation model.
The flexible endoscopy and in vivo MRI scan are both taken approximately 6-8 weeks post-neoadjuvant treatment. The images of the rigid rectoscopy and 3D endorectal ultrasound are taken directly before TME surgery.
Measured: The tissue deformation model will be created once all required data (e.g. MRI scans, rectoscopy images, endorectal ultrasound images) is available (approximately 14 days post-surgery for the final included patient).
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant as seen by eye and/or on imaging
The tissue deformation factor/model and the location of the microscopic tumor spread in relation to the macroscopic remnant determined during pathological analysis, will be used to determine the maximum distance of microscopic tumor spread in relation to the macroscopic tumor as seen by eye (rectoscopically/endoscopically) and/or on imaging (endo-ultrasound, MRI) per patient in all directions.
The flexible endoscopy and in vivo MRI scan are both taken approximately 6-8 weeks post-neoadjuvant treatment. The images of the rigid rectoscopy and 3D endorectal ultrasound are taken directly before TME surgery.
Measured: When the tissue deformation model is finished (approximately 3 months after all data for every patient is available). For the imaging time frames: please refer to the description.
Treatment margin (in the various directions) relative to the macroscopic tumor to cover 90% and 95% of all microscopic tumor spread
Distance that covers the microscopic tumor spread in all directions in millimeters for 90 and 95% of patients, including 95% confidence intervals, both reported including and excluding ypT0 patients. Reported both by eye and on imaging, for which among others the tissue deformation model will be used.
Measured: Once the microscopic tumor spread is determined for all patients (approximately 14 days post-surgery for the final included patient), the treatment margins will be calculated.
Evaluation of risk factors for the presence and/or the extent of microscopic tumor spread identified by the meta-analysis we performed
These risk factors include pathological T stage after chemoradiation (ypT stage) and time interval between neoadjuvant chemoradiotherapy and surgery.
Measured: ypT stage is determined during post-resection pathological analysis (i.e. approximately 14 days post-resection). The time interval is determined at the day of surgery.

Timeline

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

16 Aug 2022Dec 2027

First posted16 Jun 2021
Study start16 Aug 2022
Primary completionMay 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Rectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927897
Sponsor's protocol ID: NL77886.068.21
Acronym: DETECT
Status last verified: Oct 2026
First submitted: 9 Jun 2021
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data will not be shared with other researchers, however the following applies if patients have given specific, additional consent: If patients have consented to the use of leftover body material and/or data in further studies, the deidentified images (endoscopy, rectoscopy, ultrasound, in vivo MRIs and specimen MRIs) and pathological specimens/samples including (re)biopsies, and the accompanying data can be used for further scientific research related to rectal cancer by the investigators, including investigators from collaborating institutions, without requiring additional informed consent.

Publications

van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17.
PubMed 21596621
Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.
PubMed 19269519
Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, Rutten H, Pahlman L, Glimelius B, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007 Nov;246(5):693-701. doi: 10.1097/01.sla.0000257358.56863.ce.
PubMed 17968156
Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.
PubMed 22067400
Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.
PubMed 20692872
Rijkmans EC, Cats A, Nout RA, van den Bongard DHJG, Ketelaars M, Buijsen J, Rozema T, Franssen JH, Velema LA, van Triest B, Marijnen CAM. Endorectal Brachytherapy Boost After External Beam Radiation Therapy in Elderly or Medically Inoperable Patients With Rectal Cancer: Primary Outcomes of the Phase 1 HERBERT Study. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):908-917. doi: 10.1016/j.ijrobp.2017.01.033. Epub 2017 Jan 20.
PubMed 28366579
Sun Myint A, Smith FM, Gollins S, Wong H, Rao C, Whitmarsh K, Sripadam R, Rooney P, Hershman M, Pritchard DM. Dose Escalation Using Contact X-ray Brachytherapy After External Beam Radiotherapy as Nonsurgical Treatment Option for Rectal Cancer: Outcomes From a Single-Center Experience. Int J Radiat Oncol Biol Phys. 2018 Mar 1;100(3):565-573. doi: 10.1016/j.ijrobp.2017.10.022. Epub 2017 Oct 20.
PubMed 29229327
Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
PubMed 26156652
Garant A, Magnan S, Devic S, Martin AG, Boutros M, Vasilevsky CA, Ferland S, Bujold A, DesGroseilliers S, Sebajang H, Richard C, Vuong T. Image Guided Adaptive Endorectal Brachytherapy in the Nonoperative Management of Patients With Rectal Cancer. Int J Radiat Oncol Biol Phys. 2019 Dec 1;105(5):1005-1011. doi: 10.1016/j.ijrobp.2019.08.042. Epub 2019 Aug 30.
PubMed 31476417
Verrijssen AS, Opbroek T, Bellezzo M, Fonseca GP, Verhaegen F, Gerard JP, Sun Myint A, Van Limbergen EJ, Berbee M. A systematic review comparing radiation toxicity after various endorectal techniques. Brachytherapy. 2019 Jan-Feb;18(1):71-86.e5. doi: 10.1016/j.brachy.2018.10.001. Epub 2018 Nov 3.
PubMed 30396854
Smith FM, Rao C, Oliva Perez R, Bujko K, Athanasiou T, Habr-Gama A, Faiz O. Avoiding radical surgery improves early survival in elderly patients with rectal cancer, demonstrating complete clinical response after neoadjuvant therapy: results of a decision-analytic model. Dis Colon Rectum. 2015 Feb;58(2):159-71. doi: 10.1097/DCR.0000000000000281.
PubMed 25585073
Verrijssen AS, Guillem J, Perez R, Bujko K, Guedj N, Habr-Gama A, Houben R, Goudkade D, Melenhorst J, Buijsen J, Vanneste B, Grabsch HI, Bellezzo M, Paiva Fonseca G, Verhaegen F, Berbee M, Van Limbergen EJ. Microscopic intramural extension of rectal cancer after neoadjuvant chemoradiation: A meta-analysis based on individual patient data. Radiother Oncol. 2020 Mar;144:37-45. doi: 10.1016/j.radonc.2019.10.003. Epub 2019 Nov 9.
PubMed 31710942
Maas M, Lambregts DM, Nelemans PJ, Heijnen LA, Martens MH, Leijtens JW, Sosef M, Hulsewe KW, Hoff C, Breukink SO, Stassen L, Beets-Tan RG, Beets GL. Assessment of Clinical Complete Response After Chemoradiation for Rectal Cancer with Digital Rectal Examination, Endoscopy, and MRI: Selection for Organ-Saving Treatment. Ann Surg Oncol. 2015 Nov;22(12):3873-80. doi: 10.1245/s10434-015-4687-9. Epub 2015 Jul 22.
PubMed 26198074
Nuernberg D, Saftoiu A, Barreiros AP, Burmester E, Ivan ET, Clevert DA, Dietrich CF, Gilja OH, Lorentzen T, Maconi G, Mihmanli I, Nolsoe CP, Pfeffer F, Rafaelsen SR, Sparchez Z, Vilmann P, Waage JER. EFSUMB Recommendations for Gastrointestinal Ultrasound Part 3: Endorectal, Endoanal and Perineal Ultrasound. Ultrasound Int Open. 2019 Jan;5(1):E34-E51. doi: 10.1055/a-0825-6708. Epub 2019 Feb 5.
PubMed 30729231
Martens MH, Maas M, Heijnen LA, Lambregts DM, Leijtens JW, Stassen LP, Breukink SO, Hoff C, Belgers EJ, Melenhorst J, Jansen R, Buijsen J, Hoofwijk TG, Beets-Tan RG, Beets GL. Long-term Outcome of an Organ Preservation Program After Neoadjuvant Treatment for Rectal Cancer. J Natl Cancer Inst. 2016 Aug 10;108(12):djw171. doi: 10.1093/jnci/djw171. Print 2016 Dec.
PubMed 27509881

Interested in taking part?

Maaike Berbée, MD, PhD

0031884455600

maaike.berbee@maastro.nl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DETECT: Defining the Target Volume for Endoluminal Radiation Boosting in Patients With Rectal Cancer
ClinicalTrials.gov ID: NCT04927897
Acronym / sponsor ID: DETECT / NL77886.068.21
Conditions: Rectal Cancer
Keywords: Rectal Cancer, Microscopic Tumor Spread, Target Volume Definition, Endoluminal Radiation Boosting
Study type: Observational
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Maastricht Radiation OncologyUniversity, hospital or other
Collaborators: Maastricht University Medical Center, Catharina Ziekenhuis Eindhoven
Study start: 16 Aug 2022 (actual)
Primary completion: May 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 16 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This data will be used for target volume definition in rectal endoluminal radiation boosting.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational	–	Diagnostic Test: Ultrasound, Diagnostic Test: Rectoscopy, Other: Scan, e.g. CT (resection specimen)In addition to standard workup and treatment, patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these are not part of standard workup yet.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with a limited (ycT1-3N0) residual tumor after neoadjuvant radiotherapy or long-course chemoradiotherapy for rectal adenocarcinoma.

Key inclusion criteria (5 listed)

≥18 years of age and capable of giving informed consent.
ycT1-3N0(*) residual(**) histology confirmed rectal adenocarcinoma after neoadjuvant radiotherapy or long-course chemoradiotherapy for which patients will undergo TME surgery.
Minimal interval between end of neoadjuvant chemoradiotherapy or radiotherapy: 6 weeks.
()= as determined by clinical assessment (digital rectal examination, endoscopy with or without biopsy) and/or MRI. Biopsy/histology around the time of diagnosis is adequate; no biopsy/histology is needed after neoadjuvant therapy.
()= including tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These patients will also be included after the local recurrence has been determined using endoscopy and/or MRI.

Key exclusion criteria (5 listed)

Patient has received brachytherapy as part of neoadjuvant treatment.
<18 years of age or incapable of giving informed consent.
Patient has not been treated with neoadjuvant radiotherapy or long-course chemoradiotherapy.
Patient will not undergo TME surgery for a ycT1-3N0 residual histology confirmed rectal adenocarcinoma.
Interval between end of neoadjuvant therapy and surgery is <6 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ultrasound3D endorectal ultrasound.	Diagnostic test	Observational
RectoscopyRigid rectoscopy.	Diagnostic test	Observational
Scan, e.g. CT (resection specimen)For some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.	Other	Observational

Primary outcome

Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen
Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
The maximum distance of microscopic tumor spread in all directions from the macroscopic remnant in the specimen will be measured per patient in millimeters by the pathology department in the pathologic resection specimens.

8 secondary outcomes

Maximum distance of microscopic tumor spread per patient from the macroscopic tumor remnant in the pathology specimen, reported separately for MTS perpendicular to the bowel wall and for MTS parallel to the bowel wall
Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen excluding ypT0 patients
Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only including patients with microscopic tumor spread
Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only for patients with regrowths
Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)
Tissue deformation factor/model to compensate for tissue deformation due to removal of the specimen from the body, formalin fixation and tissue processing at the pathology department
Time frame: The tissue deformation model will be created once all required data (e.g. MRI scans, rectoscopy images, endorectal ultrasound images) is available (approximately 14 days post-surgery for the final included patient).
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant as seen by eye and/or on imaging
Time frame: When the tissue deformation model is finished (approximately 3 months after all data for every patient is available). For the imaging time frames: please refer to the description.
Treatment margin (in the various directions) relative to the macroscopic tumor to cover 90% and 95% of all microscopic tumor spread
Time frame: Once the microscopic tumor spread is determined for all patients (approximately 14 days post-surgery for the final included patient), the treatment margins will be calculated.
Evaluation of risk factors for the presence and/or the extent of microscopic tumor spread identified by the meta-analysis we performed
Time frame: ypT stage is determined during post-resection pathological analysis (i.e. approximately 14 days post-resection). The time interval is determined at the day of surgery.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Background: PubMed 21596621van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17.
Background: PubMed 19269519Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.
Background: PubMed 17968156Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, Rutten H, Pahlman L, Glimelius B, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007 Nov;246(5):693-701. doi: 10.1097/01.sla.0000257358.56863.ce.
Background: PubMed 22067400Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.
Background: PubMed 20692872Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.
Background: PubMed 28366579Rijkmans EC, Cats A, Nout RA, van den Bongard DHJG, Ketelaars M, Buijsen J, Rozema T, Franssen JH, Velema LA, van Triest B, Marijnen CAM. Endorectal Brachytherapy Boost After External Beam Radiation Therapy in Elderly or Medically Inoperable Patients With Rectal Cancer: Primary Outcomes of the Phase 1 HERBERT Study. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):908-917. doi: 10.1016/j.ijrobp.2017.01.033. Epub 2017 Jan 20.
Background: PubMed 29229327Sun Myint A, Smith FM, Gollins S, Wong H, Rao C, Whitmarsh K, Sripadam R, Rooney P, Hershman M, Pritchard DM. Dose Escalation Using Contact X-ray Brachytherapy After External Beam Radiotherapy as Nonsurgical Treatment Option for Rectal Cancer: Outcomes From a Single-Center Experience. Int J Radiat Oncol Biol Phys. 2018 Mar 1;100(3):565-573. doi: 10.1016/j.ijrobp.2017.10.022. Epub 2017 Oct 20.
Background: PubMed 26156652Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
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Individual participant dataSharing planned: No. The data will not be shared with other researchers, however the following applies if patients have given specific, additional consent: If patients have consented to the use of leftover body material and/or data in further studies, the deidentified images (endoscopy, rectoscopy, ultrasound, in vivo MRIs and specimen MRIs) and pathological specimens/samples including (re)biopsies, and the accompanying data can be used for further scientific research related to rectal cancer by the investigators, including investigators from collaborating institutions, without requiring additional informed consent.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Maaike Berbée, MD, PhD contact

0031884455600

maaike.berbee@maastro.nl

Evert Van Limbergen, MD, PhD contact

0031884455600

evert.vanlimbergen@maastro.nl

Maaike Berbée, MD, PhD principal investigator

Maastro

Evert Van Limbergen, MD, PhD principal investigator

Maastro

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer, run by Maastricht Radiation Oncology at 3 sites in Netherlands.

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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Maaike Berbée, MD, PhD (0031884455600, maaike.berbee@maastro.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen (time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)). 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 NCT04927897, which also lists 23 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 9 Oct 2026.