Rectal NeoplasmsNCT04095468
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
An observational study of Rectal Neoplasms and Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 7 sites in Poland.
Trial summary
Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms, Rectal Cancer
- What is being tested?
- Preoperative Radio(Chemo)Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 215 participants
- Where
- 7 sitesPoland
- Study dates
- 18 Sep 2017to 1 Jan 2026
- 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: 140 patients with "resectable" cancer and 75 patients with threatened mesorectal fascia as assessed on multidisciplinary tumor board.
Who may be able to join
- Primary rectal cancer
- Low tumour (accessible by digital rectal examination)
- Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.
- Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR
Who cannot join
- Recurrent cancer
- Cancers situated in the upper rectum
- Distant metastases
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Poland7 sites, 7 recruiting
- Recruiting
Collegium Medicum Nicolaus Copernicus University and Oncology Centre
Bydgoszcz
Michał Jankowski, M.D.
Michał Jankowski, M.D.
- Recruiting
Regional Oncological Centre
Kielce
Jacek Sadowski, M.D.
Jacek Sadowski, M.D.
- Not yet recruiting
Jagiellonian Medical University College
Krakow
Piotr Richter, M.D.
Piotr Richter, M.D.
- Recruiting
St. John's Cancer Center
Lublin
Małgorzata Jankiewicz, M.D.
Małgorzata Jankiewicz, M.D.
- Recruiting
Maria Skłodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, 02-781
Krzysztof Bujko, M.D. PhD, +48601207466, Krzysztof.Bujko@coi.pl
Krzysztof Bujko, M.D. PhD
- Recruiting
Silesian Oncological Centre
Wroclaw
Jolanta Szelachowska, M.D.
Jolanta Szelachowska, M.D.
- Recruiting
NU-MED Centre for Cancer Diagnosis and Treatment
Zamość
Marek Mazurek, M.D.
Marek Mazurek, M.D.
About this study
Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. This proportion in population-based level is poorly defined. In addition, predictive factors for cCR are also poorly defined. It is known that cCR response is observed often in small tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For example, even though pathological complete response (pCR) does occur in large fixed cancer, it is unknown whether cCR does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases.
This is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.
- Conditions
- Rectal Neoplasms, Rectal Cancer
- Being tested
- Preoperative Radio(Chemo)Therapy
- Keywords
- rectal cancer, preoperative radiotherapy, organ preservation, watch-and-wait
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Radio(Chemo)TherapyRadiation
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
| Study group | Role | What they receive |
|---|---|---|
| Resectable rectal cancer | Not described Receives: Radiation: Preoperative Radio(Chemo)Therapy | |
| Rectal cancer with threatened mesorectal fascia | Not described Receives: Radiation: Preoperative Radio(Chemo)Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of cCR and near-cCR in the patients with "resectable" cancer
Measured: 11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia.
Measured: 11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in relation to the selected tumour characteristics.
The selected tumour characteristics: TN categories, tumour length, degree of circumferential involvement, tumour mobility on digital rectal examination (mobile, tethered, fixed) and status of mesorectal fascia (threatened or not).
Measured: 11 weeks from the start of radiotherapy
Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.
Measured: 12 weeks from the start of radiotherapy
Secondary outcomes (4)
Local regrowth rate
Measured: 5 years
Disease-free survival
Measured: 3 years
Overall survival
Measured: 5 years
Anorectal function assessed by low anterior resection syndrome (LARS) score
The questionnaire will be completed by patients. It includes 5 items related to anorectal function. The range of the score (0-42) is divided into 0 to 20 (no LARS), 21 to 29 (minor LARS) and 30 to 42 (major LARS).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start18 Sep 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Society of Surgical Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095468
- Sponsor's protocol ID
- ORGANPRESERV1
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04095468
- Acronym / sponsor ID
- ORGANPRESERV1
- Conditions
- Rectal Neoplasms, Rectal Cancer
- Keywords
- rectal cancer, preoperative radiotherapy, organ preservation, watch-and-wait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Polish Society of Surgical Oncology
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 19 Sep 2019 (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.
Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. This proportion in population-based level is poorly defined. In addition, predictive factors for cCR are also poorly defined. It is known that cCR response is observed often in small tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For example, even though pathological complete response (pCR) does occur in large fixed cancer, it is unknown whether cCR does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases.
This is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable rectal cancer | – | Radiation: Preoperative Radio(Chemo)Therapy |
| Rectal cancer with threatened mesorectal fascia | – | Radiation: Preoperative Radio(Chemo)Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 140 patients with "resectable" cancer and 75 patients with threatened mesorectal fascia as assessed on multidisciplinary tumor board.
Key inclusion criteria (4 listed)
- Primary rectal cancer
- Low tumour (accessible by digital rectal examination)
- Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.
- Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR
Key exclusion criteria (3 listed)
- Recurrent cancer
- Cancers situated in the upper rectum
- Distant metastases
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 |
|---|---|---|
| Preoperative Radio(Chemo)TherapyPreoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait | Radiation | Rectal cancer with threatened mesorectal fascia, Resectable rectal cancer |
Primary outcome
Percentages of cCR and near-cCR in the patients with "resectable" cancer
Time frame: 11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia.
Time frame: 11 weeks from the start of radiotherapy
Percentages of cCR and near-cCR in relation to the selected tumour characteristics.
Time frame: 11 weeks from the start of radiotherapy
The selected tumour characteristics: TN categories, tumour length, degree of circumferential involvement, tumour mobility on digital rectal examination (mobile, tethered, fixed) and status of mesorectal fascia (threatened or not).
Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.
Time frame: 12 weeks from the start of radiotherapy
4 secondary outcomes
Local regrowth rate
Time frame: 5 years
Disease-free survival
Time frame: 3 years
Overall survival
Time frame: 5 years
Anorectal function assessed by low anterior resection syndrome (LARS) score
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
7 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 Neoplasms and Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 7 sites in Poland.
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 4 inclusion and 3 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 19 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 7 sites in Poland. 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?
Contact Krzysztof Bujko, M.D. PhD (+48601207466, Krzysztof.Bujko@coi.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of cCR and near-cCR in the patients with "resectable" cancer (time frame: 11 weeks from the start of radiotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2019.