Rectal CancerCRONOSNCT04717947
Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer (CRONOS)
An observational study of Rectal Cancer and Neoadjuvant Therapy, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Neoadjuvant Therapy
- What is being tested?
- Interval between NAT and surgery
- Type of treatment
- Surgery or procedure
- How many people
- 911 participants
- Where
- 1 siteSpain
- Study dates
- 25 Feb 2020to 25 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a national multicentre retrospective cohort study. Participating centres are tertiary referral hospitals from different Spanish regions, which agreed to enter information in a standardized database, of all patients in their institute who had biopsy-confirmed rectal adenocarcinoma and had received neoadjuvant therapy. All patients with low, mid and high rectal cancer (0-15 cm from the anal verge), at a clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) will be included.
Who may be able to join
- Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
- Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
- Patients treated with short-course radiotherapy with delayed surgery.
- Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging
Who cannot join
- Intolerance or contraindication to planned NAT.
- Patients who have not finished NAT for any reason.
- Patients with unknown cT or cM.
- Tumors previously treated with local excision or with distant metastatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer
The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.
Read the detailed description
In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. This optimal interval is yet to be defined. This study will aim to better define the role of time interval between the end of neoadjuvant therapy (NAT) and TME in Spanish regions, together with analyzing the importance of restaging MRI and define the basis for implementing a "watch and wait" protocol.
- Conditions
- Rectal Cancer, Neoadjuvant Therapy
- Being tested
- Interval between NAT and surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval between NAT and surgeryProcedure or surgery
Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.
| Study group | Role | What they receive |
|---|---|---|
| Short interval group | ≤ 8weeks between the end of neoadjuvant therapy and surgery Receives: Procedure: Interval between NAT and surgery | |
| Intermediate interval group | > 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery Receives: Procedure: Interval between NAT and surgery | |
| Long interval group | > 12 weeks between the end of neoadjuvant therapy and surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response
Grade as complete
Measured: 2000-2019
Circumferential margin (CRM)
Described as free (CRM >1 mm)
Measured: 2000-2019
Distal resection margin (DRM)
Described as free (DRM >1 mm)
Measured: 2000-2019
Quality of the specimen
Described as complete or incomplete
Measured: 2000-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Feb 2020
- Primary completion25 Feb 2020
- Study completion25 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Retrospective
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Santiago, Hospital Universitario Marqués de Valdecilla, Hospital de Sant Joan Despí Moisès Broggi, Hospital del Mar, Hospital Son Espases, Hospital Universitario La Fe, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
- Responsible party
- Sponsor
- Investigators
- Antonio Lacy, PhD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717947
- Sponsor's protocol ID
- HCB/2019/1109
- Acronym
- CRONOS
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04717947
- Acronym / sponsor ID
- CRONOS / HCB/2019/1109
- Conditions
- Rectal Cancer, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 911 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Santiago, Hospital Universitario Marqués de Valdecilla, Hospital de Sant Joan Despí Moisès Broggi, Hospital del Mar, Hospital Son Espases, Hospital Universitario La Fe, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Jun 2021 (estimated)
- First posted
- 22 Jan 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.
The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.
Detailed description
In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. This optimal interval is yet to be defined. This study will aim to better define the role of time interval between the end of neoadjuvant therapy (NAT) and TME in Spanish regions, together with analyzing the importance of restaging MRI and define the basis for implementing a "watch and wait" protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short interval group | – | Procedure: Interval between NAT and surgery≤ 8weeks between the end of neoadjuvant therapy and surgery |
| Intermediate interval group | – | Procedure: Interval between NAT and surgery> 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery |
| Long interval group | – | –> 12 weeks between the end of neoadjuvant therapy and surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a national multicentre retrospective cohort study. Participating centres are tertiary referral hospitals from different Spanish regions, which agreed to enter information in a standardized database, of all patients in their institute who had biopsy-confirmed rectal adenocarcinoma and had received neoadjuvant therapy. All patients with low, mid and high rectal cancer (0-15 cm from the anal verge), at a clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) will be included.
Key inclusion criteria (4 listed)
- Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
- Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
- Patients treated with short-course radiotherapy with delayed surgery.
- Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging
Key exclusion criteria (4 listed)
- Intolerance or contraindication to planned NAT.
- Patients who have not finished NAT for any reason.
- Patients with unknown cT or cM.
- Tumors previously treated with local excision or with distant metastatic disease.
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 |
|---|---|---|
| Interval between NAT and surgeryEvaluate three groups according to the interval between the end of neoadjuvant therapy and surgery. | Procedure or surgery | Intermediate interval group, Short interval group |
Primary outcome
Pathological response
Time frame: 2000-2019
Grade as complete
Circumferential margin (CRM)
Time frame: 2000-2019
Described as free (CRM >1 mm)
Distal resection margin (DRM)
Time frame: 2000-2019
Described as free (DRM >1 mm)
Quality of the specimen
Time frame: 2000-2019
Described as complete or incomplete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Antonio Lacy, PhD study director
Hospital Clinic of Barcelona
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 Cancer and Neoadjuvant Therapy, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 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 4 Feb 2021. 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 Spain. 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?
Pathological response (time frame: 2000-2019). 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 4 Feb 2021.