An observational study in Rectal Neoplasms, sponsored by The Netherlands Cancer Institute. Recruiting at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by The Netherlands Cancer Institute · Observational
The aim of this prospective observational cohort study is to provide short and long term oncological and functional outcome data on organ preserving treatment in good responders after a standard indication for neoadjuvant (chemo)radiation for rectal cancer.
Standard treatment for patients with locally advanced rectal cancer consists of a long course of (CRT) followed by surgical resection. Although the aim of neoadjuvant treatment in these patients is not organ preservation, but rather to provide improved local control, in the tumour disappears completely. Studies from Maastricht, the UK and Brazil have shown that in selected patients with a clinical complete response after CRT, a "wait-and-see" policy without any surgery could be a safe alternative with comparable long-term outcome and better functional outcome compared to patients who had surgery.
The main objective of the study is to provide short and long term oncological and functional outcome data on organ preserving treatment in good responders after a standard indication for neoadjuvant (chemo)radiation. Additional aims are: to set up a national network with expertise centres in the 'wait-and-see' treatment of rectal cancer; to set up a national registry for organ preservation treatment that will generate more evidence on the management and oncological outcome of patients evaluated and treated with organ preservation and [3] to offer through this network to all patients who are considered good candidates this 'wait-and-see' approach using the most up to date tools for selection and follow-up.
Study design: multicenter prospective observational cohort study and implementation study. Study population: The population will consist of patients, aged 18 years or older, with rectal cancer who after a long course of CRT or a short course of radiation with a long waiting interval have a clinical complete response (ycT0N0).
The main study endpoint is 2-year non-regrowth disease-free survival. Secondary endpoints are [1] the number of fully operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands, [2] 2-year regrowth rate, [3] 2-year local control, [4] 2-year overall survival, [5] determination of the optimal follow-up schedule and [6] quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the majority of patients who participate in the study, major surgery and the associated morbidity can be avoided. Although scientific proof shows "wait-and-see" only comes with a small risk with adequate selection and follow up, the exact risk is not yet well established and needs to be confirmed by this study. The benefit-risk ratio for this study is regarded as favourable.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 220 is above the median of 161 across 498 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 231 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population will consist of patients, aged 18 years or older, with rectal cancer who after a long course of CRT or a short course of radiation with a long waiting interval have a clinical complete response (ycT0N0), as determined by MRI (including DWI) and digital rectal examination + endoscopy. Only patients who fulfill the predefined list of criteria for a clinical complete response will be considered eligible for inclusion in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2-year non-regrowth disease-free survival
Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up
Time frame: 2 years after start of wait-and-see protocol
Number of fully operational centres
Number of operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands
Time frame: 2 years after start of wait-and-see protocol
2-year local regrowth rate
The proportion of local regrowth
Time frame: 2 years after start of wait-and-see protocol
2-year local control
Absence of local recurrence(unresectable regrowth, resected with R1, or requiring more extensive than TME surgery) or death
Time frame: 2 years after start of wait-and-see protocol
2-year overall survival
Absence of death
Time frame: 2 years after start of wait-and-see protocol
Determination of the optimal follow-up schedule
A balance between early detection of recurrence and compliance to follow-up
Time frame: 2 years after start of wait-and-see protocol
Quality of life
Quality of life (general health, disease specific and functional outcomes)
Time frame: At 3 months, 1 year, 2 years and 5 years after the start of wait-and-see protocol
Plan to share: No
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Jun 2021, 48 months after the start.
Of 213 non-industry observational studies under Rectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 48 months is close to that.
Counting every sponsor, half of 228 studies reached it within 45 months; a quarter within 24 and three quarters within 116.
How these figures are worked out, and which studies are left out of them.
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