Rectal Cancer, AdenocarcinomaNCT05495308
"Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".
An observational study of Rectal Cancer, Adenocarcinoma and Rectal Cancer Stage II, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma, Rectal Cancer Stage II, Rectal Cancer Stage III
- What is being tested?
- neoadjuvant treatment
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 1 May 2022
- How long will I take part?
- 80 Months
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR
Who may be able to join
- Patients with pathological confirmation of rectal cancer preoperatively, in any of its histological variants.
- Tumor located less than 12 cm from the anal margin.
- Radiological stage II or III (cT3-4 N0 and/or any T with positive cN).
- Neoadjuvant treatment with radio-chemotherapy.
- Radical surgery performed on a scheduled basis and with curative intent.
- Definitive pathology study with complete tumor regression.
Who cannot join
- Patients operated on with palliative intent.
- Patients diagnosed with a hereditary colorectal cancer syndrome.
- Patients who presented synchronous metastases at the time of diagnosis, or concurrent malignancy of another origin.
- Patients who underwent emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce.
This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database.
Read more
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies.
All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).
- Conditions
- Rectal Cancer, Adenocarcinoma, Rectal Cancer Stage II, Rectal Cancer Stage III, Distant Metastasis, Local Recurrence of Malignant Tumor of Rectum
- Being tested
- neoadjuvant treatment
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant treatmentProcedure or surgery
We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| NON-DISTANT METASTASES | Those patiens who do not develop distant metastasis during the follow-up time. Receives: Procedure: neoadjuvant treatment | |
| DISTANT METASTASES | Those patiens who develop distant metastasis during the follow-up time. Receives: Procedure: neoadjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Measured: May 2022-June 2022
Secondary outcomes (4)
To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Operative and treatment data related to adverse oncologic outcomes.
Measured: May 2022-June 2022
To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Age (years) related to worse long-term oncologic outcomes.
Measured: May 2022-June 2022
To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Normal Pretreatment CEA (ng/dl) related to worse long-term oncologic outcomes.
Measured: May 2022-June 2022
To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Tumour location (cm) and Distance from anal verge (cm) related to worse long-term oncologic outcomes.
Measured: May 2022-June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer, AdenocarcinomaStudies 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
- 4 participants (actual)
- Target duration
- 80 Months
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Cerdán Santacruz, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495308
- Sponsor's protocol ID
- C.I. 20/741-E
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 10 Aug 2022
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
- ClinicalTrials.gov ID
- NCT05495308
- Acronym / sponsor ID
- C.I. 20/741-E
- Conditions
- Rectal Cancer, Adenocarcinoma, Rectal Cancer Stage II, Rectal Cancer Stage III, Distant Metastasis, Local Recurrence of Malignant Tumor of Rectum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Aug 2022 (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.
Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce.
This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database.
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies.
All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 80 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NON-DISTANT METASTASES | – | Procedure: neoadjuvant treatmentThose patiens who do not develop distant metastasis during the follow-up time. |
| DISTANT METASTASES | – | Procedure: neoadjuvant treatmentThose patiens who develop distant metastasis during the follow-up time. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR
Key inclusion criteria (6 listed)
- Patients with pathological confirmation of rectal cancer preoperatively, in any of its histological variants.
- Tumor located less than 12 cm from the anal margin.
- Radiological stage II or III (cT3-4 N0 and/or any T with positive cN).
- Neoadjuvant treatment with radio-chemotherapy.
- Radical surgery performed on a scheduled basis and with curative intent.
Key exclusion criteria (4 listed)
- Patients operated on with palliative intent.
- Patients diagnosed with a hereditary colorectal cancer syndrome.
- Patients who presented synchronous metastases at the time of diagnosis, or concurrent malignancy of another origin.
- Patients who underwent emergency surgery.
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 |
|---|---|---|
| neoadjuvant treatmentWe study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy. | Procedure or surgery | DISTANT METASTASES, NON-DISTANT METASTASES |
Primary outcome
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Time frame: May 2022-June 2022
Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
4 secondary outcomes
To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Time frame: May 2022-June 2022
To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Time frame: May 2022-June 2022
To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Time frame: May 2022-June 2022
To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
Time frame: May 2022-June 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Adenocarcinoma and Rectal Cancer Stage II, run by Hospital San Carlos, Madrid 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 6 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: finished, as of the sponsor's last update on 10 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR. (time frame: May 2022-June 2022). 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 10 Aug 2022.