Rectal NeoplasmsNCT02278653
Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer
An observational study of Rectal Neoplasms, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Questionnaires for the evaluation of Quality of Life and Manometry
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Sep 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0). Patients will be recruited from the outpatient clinic, by researchers or research nurses at Maastricht University Medical Center.
Who may be able to join
- 18 years old
- Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
- Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
- Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor
- Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
- Choosing for the organ-saving treatment option (wait\&see policy or TEM)
- Informed consent
Who cannot join
- Unable to understand or read Dutch
- Unwilling to comply to the questionnaires or manometric measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow up and Functional Outcome of Organ Saving Treatment in Patients With Good Response to Neo-adjuvant (Chemo)Radiation for Rectal Cancer
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.
Read the detailed description
Rectal cancer is a common form of cancer. Standard treatment for locally advanced rectal cancer is a long course of neoadjuvant radiation combined with chemotherapy (CRT) followed by resection. However, neoadjuvant CRT induces downsizing and downstaging, resulting in a complete response in 15-20% of the patients. In these patients surgery may be omitted. In the investigators previous study the investigators obtained good results with an organ saving treatment. Although the mortality and morbidity associated with radical surgery is avoided, the irradiated rectum remains in situ, possibly causing functional problems.
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment. Functional outcome will be evaluated with questionnaires (quality of life) and manometric measurements (maximal resting pressure, maximal squeezing pressure, sphincter length, percentage asymmetry of the resting sphincter, sustained duration, length of the high pressure zone, rectoanal inhibitory reflex, rectal sensory threshold, and rectal compliance).
Secondary objectives include: the estimation of the cumulative risk of local failure within 5 years, the estimation of the cumulative risk of disease-free, distant-metastasis-free and overall survival within 5 years, determine the percentage of patients that chooses organ saving treatment instead of standard resection, determine the compliance to intensive follow-up, and compare the cost-effectiveness of organ saving treatment to standard surgical resection over a period of 5 years. These objectives will be assessed by frequent revision of the electronic patient file, as the patient is followed up to four times per year.
Study design: prospective observational registration study with 'invasive diagnostic procedures' Study population: The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).
Main study parameters/endpoints: The main study endpoint is the functional outcome scores based on questionnaires and manometric measurements Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The questionnaires take approximately 20 minutes to complete. There is a relatively low rate of side effects associated with manometric measurements. Results of this study will contribute to better understanding of functional complaints after rectal cancer treatment.
- Conditions
- Rectal Neoplasms
- Being tested
- Questionnaires for the evaluation of Quality of Life, Manometry
- Keywords
- Restaging, Watchful Waiting, Quality of Life, Manometry
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires for the evaluation of Quality of LifeOther
- European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
- Short Form (36) health survey
- EORTC CR38
- Vaizey score
- Low Anterior Resection Syndrome (LARS) score
- International Index of Erectile Function for men
- International Prostate Symptom Score for men
- Female Sexual Function Index for women
ManometryOther
Manometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up).
| Study group | Role | What they receive |
|---|---|---|
| Study group | The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0). Receives: Other: Questionnaires for the evaluation of Quality of Life; Other: Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature.
Functional outcome will be evaluated with the following questionnaires:
- European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
- Short Form (36) health survey
- EORTC CR38
- Vaizey score
- Low Anterior Resection Syndrome (LARS) score
- International Index of Erectile Function for men
- International Prostate Symptom Score for men
- Female Sexual Function Index for women
Functional outcome will be measured by manometric measurements:
- mean basal pressure (mmH2O)
- maximum squeeze pressure (mmH2O)
- first sensation (mL)
- first urge to defecate (mL)
- maximum tolerable volume (mL)
Measured: 5 years
Secondary outcomes (5)
Cumulative risk of local failure
All patients with a local recurrence will be excluded form further follow-up. This information will be based on an MRI of the lower abdomen in combination with endoscopy.
Measured: 5 years
Cumulative risks of disease-free, distant-metastasis free and overall survival
Measured: 5 years
The percentage of patients that choose the alternative strategies instead of traditional strategies and the motivation for their choice
Measured: 3 years
The compliance to the intensive follow-up schedule
All patients are intended to participate in the standard follow-up schedule. Some of them may drop out due to other illness, ageing or other reasons. These patients will be included in the analysis as far as they participated.
Measured: 5 years
Early detection of local failure (standard surgery still possible)
In the first year, every three months an MRI of the lower abdomen is made in combination with an endoscopy. From the second to the fifth year, these investigations will be done twice a year. With these short intervals, it is know that local recurence is detected in an early fase.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Geerard L Beets, MD, PhD, Principal investigator, Surgery, MUMC+Rianne CJ Beckers, MD, MSc, Study chair, Surgery/Radiology MUMC+Miriam M van Heeswijk, MD, MSc, Study chair, Surgery/Radiology MUMC+Monique Maas, MD, PhD, Study chair, Radiology, MUMC+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278653
- Sponsor's protocol ID
- NL49171.068.14
- Status last verified
- Sep 2019
- First submitted
- 6 Oct 2014
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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 22067400Maas 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 20692872Habr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005.
PubMed 17175450Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1.
PubMed 21239980Lambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23.
PubMed 21347783Curvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14.
PubMed 21673229Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89.
PubMed 21178866Lambregts DM, Maas M, Bakers FC, Cappendijk VC, Lammering G, Beets GL, Beets-Tan RG. Long-term follow-up features on rectal MRI during a wait-and-see approach after a clinical complete response in patients with rectal cancer treated with chemoradiotherapy. Dis Colon Rectum. 2011 Dec;54(12):1521-8. doi: 10.1097/DCR.0b013e318232da89.
PubMed 22067180Geubels BM, Maas M, Beets GL, Grotenhuis BA; Dutch Watch-and-Wait Consortium. What To Do With Suspected Nodal Regrowth on MRI During Follow-Up in an Organ Preservation Approach for Rectal Cancer? Dis Colon Rectum. 2024 Dec 1;67(12):1528-1535. doi: 10.1097/DCR.0000000000003385. Epub 2024 Sep 6.
PubMed 39250317Haak HE, Zmuc J, Lambregts DMJ, Beets-Tan RGH, Melenhorst J, Beets GL, Maas M; Dutch Watch-and-Wait Consortium. The evaluation of follow-up strategies of watch-and-wait patients with a complete response after neoadjuvant therapy in rectal cancer. Colorectal Dis. 2021 Jul;23(7):1785-1792. doi: 10.1111/codi.15636. Epub 2021 Apr 2.
PubMed 33725387
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up and Functional Outcome of Organ Saving Treatment in Patients With Good Response to Neo-adjuvant (Chemo)Radiation for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02278653
- Acronym / sponsor ID
- NL49171.068.14
- Conditions
- Rectal Neoplasms
- Keywords
- Restaging, Watchful Waiting, Quality of Life, Manometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Mar 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 30 Oct 2014 (estimated)
- 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.
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.
Detailed description
Rectal cancer is a common form of cancer. Standard treatment for locally advanced rectal cancer is a long course of neoadjuvant radiation combined with chemotherapy (CRT) followed by resection. However, neoadjuvant CRT induces downsizing and downstaging, resulting in a complete response in 15-20% of the patients. In these patients surgery may be omitted. In the investigators previous study the investigators obtained good results with an organ saving treatment. Although the mortality and morbidity associated with radical surgery is avoided, the irradiated rectum remains in situ, possibly causing functional problems.
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment. Functional outcome will be evaluated with questionnaires (quality of life) and manometric measurements (maximal resting pressure, maximal squeezing pressure, sphincter length, percentage asymmetry of the resting sphincter, sustained duration, length of the high pressure zone, rectoanal inhibitory reflex, rectal sensory threshold, and rectal compliance).
Secondary objectives include: the estimation of the cumulative risk of local failure within 5 years, the estimation of the cumulative risk of disease-free, distant-metastasis-free and overall survival within 5 years, determine the percentage of patients that chooses organ saving treatment instead of standard resection, determine the compliance to intensive follow-up, and compare the cost-effectiveness of organ saving treatment to standard surgical resection over a period of 5 years. These objectives will be assessed by frequent revision of the electronic patient file, as the patient is followed up to four times per year.
Study design: prospective observational registration study with 'invasive diagnostic procedures' Study population: The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).
Main study parameters/endpoints: The main study endpoint is the functional outcome scores based on questionnaires and manometric measurements Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The questionnaires take approximately 20 minutes to complete. There is a relatively low rate of side effects associated with manometric measurements. Results of this study will contribute to better understanding of functional complaints after rectal cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Questionnaires for the evaluation of Quality of Life, Other: ManometryThe population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0). Patients will be recruited from the outpatient clinic, by researchers or research nurses at Maastricht University Medical Center.
Key inclusion criteria (7 listed)
- 18 years old
- Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
- Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
- Choosing for the organ-saving treatment option (wait\&see policy or TEM)
- Informed consent
Key exclusion criteria (2 listed)
- Unable to understand or read Dutch
- Unwilling to comply to the questionnaires or manometric measurement.
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 |
|---|---|---|
| Questionnaires for the evaluation of Quality of Life1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score 2. Short Form (36) health survey 3. EORTC CR38 4. Vaizey score 5. Low Anterior Resection Syndrome (LARS) score 6. International Index of Erectile Function for men 7. International Prostate Symptom Score for men 8. Female Sexual Function Index for women | Other | Study group |
| ManometryManometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up). | Other | Study group |
Primary outcome
Functional outcome
Time frame: 5 years
Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature. Functional outcome will be evaluated with the following questionnaires: 1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score 2. Short Form (36) health survey 3. EORTC CR38 4. Vaizey score 5. Low Anterior Resection Syndrome (LARS) score 6. International Index of Erectile Function for men 7. International Prostate Symptom Score for men 8. Female Sexual Function Index for women Functional outcome will be measured by manometric measurements: 1. mean basal pressure (mmH2O) 2. maximum squeeze pressure (mmH2O) 3. first sensation (mL) 4. first urge to defecate (mL) 5. maximum tolerable volume (mL)
5 secondary outcomes
Cumulative risk of local failure
Time frame: 5 years
Cumulative risks of disease-free, distant-metastasis free and overall survival
Time frame: 5 years
The percentage of patients that choose the alternative strategies instead of traditional strategies and the motivation for their choice
Time frame: 3 years
The compliance to the intensive follow-up schedule
Time frame: 5 years
Early detection of local failure (standard surgery still possible)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- 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 17175450Habr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005.
- Background: PubMed 21239980Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1.
- Background: PubMed 21347783Lambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23.
- Background: PubMed 21673229Curvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14.
- Background: PubMed 21178866Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89.
- Background: PubMed 22067180Lambregts DM, Maas M, Bakers FC, Cappendijk VC, Lammering G, Beets GL, Beets-Tan RG. Long-term follow-up features on rectal MRI during a wait-and-see approach after a clinical complete response in patients with rectal cancer treated with chemoradiotherapy. Dis Colon Rectum. 2011 Dec;54(12):1521-8. doi: 10.1097/DCR.0b013e318232da89.
- Derived from this study: PubMed 39250317Geubels BM, Maas M, Beets GL, Grotenhuis BA; Dutch Watch-and-Wait Consortium. What To Do With Suspected Nodal Regrowth on MRI During Follow-Up in an Organ Preservation Approach for Rectal Cancer? Dis Colon Rectum. 2024 Dec 1;67(12):1528-1535. doi: 10.1097/DCR.0000000000003385. Epub 2024 Sep 6.
- Derived from this study: PubMed 33725387Haak HE, Zmuc J, Lambregts DMJ, Beets-Tan RGH, Melenhorst J, Beets GL, Maas M; Dutch Watch-and-Wait Consortium. The evaluation of follow-up strategies of watch-and-wait patients with a complete response after neoadjuvant therapy in rectal cancer. Colorectal Dis. 2021 Jul;23(7):1785-1792. doi: 10.1111/codi.15636. Epub 2021 Apr 2.
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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. This study is not recruiting at the moment.
Geerard L Beets, MD, PhD principal investigator
Surgery, MUMC+
Rianne CJ Beckers, MD, MSc study chair
Surgery/Radiology MUMC+
Miriam M van Heeswijk, MD, MSc study chair
Surgery/Radiology MUMC+
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Maastricht University Medical Center at 1 site 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Functional outcome (time frame: 5 years). 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 NCT02278653, which also lists 10 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 18 Sep 2019.