Colorectal NeoplasmsNCT05322486
Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
An observational study of Colorectal Neoplasms and Intestinal Neoplasms, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms
- What is being tested?
- surgery of the primary tumour and chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 29 Oct 2020to Dec 2022
- 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: Patients who were diagnosed with colorectal cancer and synchronous unresectable metastases between 2016 and 2022 from our institutional database.
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma
- Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis
- Age ≥ 18 years
- Informed consent
Who cannot join
- Synchronous cancers
- Carcinomatosis
- Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Ryzhikh National Medical Research Center of Coloproctology
Moscow
Iuliia Alimova, MD, +7 (916) 868-80-25, doctoralimova@gmail.com
About this study
Official title: Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases Versus Chemotherapy Alone
Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.
Read the detailed description
The present study is a single-center retrospective observational cohort study with a propensity score matching. Between 2016 and 2022 from our institutional database minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases will be selected. Patients will be divided into two groups:
- Surgical resection of the primary tumour before to systemic therapy
- Systemic therapy without previous resection of the primary tumour. Propensity score matching (PSM) will be performed, to minimize the selection bias by adjusting variables that may affect the survival of patients. Categorical variables will be compared using the chi-square test or Fisher's exact test. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test. Survival rate will be determined by using Kaplan-Meier analysis with a log-rank test. Univariate and multivariate analyses for survival will be conducted using Cox proportional hazard models. Statistical results will be considered significant at p values less than 0.05.
- Conditions
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms
- Being tested
- surgery of the primary tumour, chemotherapy
- Keywords
- Colorectal cancer, Primary tumor resection, Minimally symptomatic primary tumor, Unresectable metastases, Chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Neoplasms, Second Primary, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery of the primary tumourProcedure or surgery
Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.
chemotherapyDrug
Chemotherapy with or without biological drugs.
| Study group | Role | What they receive |
|---|---|---|
| Primary tumour resection group. | Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime. Receives: Procedure: surgery of the primary tumour; Drug: chemotherapy | |
| Chemotherapy group. | Chemotherapy +/- targeted therapy alone. Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (3)
Thirty-day mortality
Measured: 30 days
Rate of surgical intervention due to complication of treatment
Measured: 1 year
Progression free survival (PFS)
PFS is defined as the time interval between the date of diagnosis and the first date of progression of the metastatic disease or death in both treatment arms.
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 posted11 Apr 2022
- Study start29 Oct 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322486
- Sponsor's protocol ID
- 22A/20
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases Versus Chemotherapy Alone
- ClinicalTrials.gov ID
- NCT05322486
- Acronym / sponsor ID
- 22A/20
- Conditions
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms
- Keywords
- Colorectal cancer, Primary tumor resection, Minimally symptomatic primary tumor, Unresectable metastases, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Apr 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.
Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.
Detailed description
The present study is a single-center retrospective observational cohort study with a propensity score matching. Between 2016 and 2022 from our institutional database minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases will be selected. Patients will be divided into two groups:
- Surgical resection of the primary tumour before to systemic therapy
- Systemic therapy without previous resection of the primary tumour. Propensity score matching (PSM) will be performed, to minimize the selection bias by adjusting variables that may affect the survival of patients. Categorical variables will be compared using the chi-square test or Fisher's exact test. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test. Survival rate will be determined by using Kaplan-Meier analysis with a log-rank test. Univariate and multivariate analyses for survival will be conducted using Cox proportional hazard models. Statistical results will be considered significant at p values less than 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary tumour resection group. | – | Procedure: surgery of the primary tumour, Drug: chemotherapySurgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime. |
| Chemotherapy group. | – | Drug: chemotherapyChemotherapy +/- targeted therapy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with colorectal cancer and synchronous unresectable metastases between 2016 and 2022 from our institutional database.
Key inclusion criteria (4 listed)
- Histologically confirmed colorectal adenocarcinoma
- Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (3 listed)
- Synchronous cancers
- Carcinomatosis
- Prior surgery, chemotherapy, radiation therapy for the primary tumor or 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 |
|---|---|---|
| surgery of the primary tumourSurgical resection of the colon tumour, R0. No surgical intervention on metastasis. | Procedure or surgery | Primary tumour resection group. |
| chemotherapyChemotherapy with or without biological drugs. | Drug | Chemotherapy group., Primary tumour resection group. |
Primary outcome
Overall survival
Time frame: 3 years
3 secondary outcomes
Thirty-day mortality
Time frame: 30 days
Rate of surgical intervention due to complication of treatment
Time frame: 1 year
Progression free survival (PFS)
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 11 Apr 2022.
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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.
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 Colorectal Neoplasms and Intestinal Neoplasms, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 11 Apr 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 Russia. 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 Iuliia Alimova, MD (+7 (916) 868-80-25, doctoralimova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). 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 11 Apr 2022.