Colon CancerNCT03561948
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
A study testing Experimental group in people with Colon Cancer, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Experimental group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2018to 10 Aug 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual:
- Histologically verified adenocarcinoma of the colon.
- Signed informed consent.
Who cannot join
- Pregnancy or lactation.
- The presence of synchronous or metachronous malignant tumors.
- Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs.
- Neoadjuvant chemotherapy.
- Suspected Lynch syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.
Read the detailed description
In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. Patients of this group will not receive intraoperative intra-abdominal chemotherapy. After performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
- Conditions
- Colon Cancer
- Being tested
- Experimental group, Control group
- Keywords
- intraperitoneal chemotherapy, Peritoneal Carcinomatosis, Colonic Diseases
- Medical subject headings
- Colonic Neoplasms, Peritoneal Neoplasms, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupProcedure or surgery
After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
Control groupProcedure or surgery
In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed with subsequent immunological examination. Patients of this group will not receive intraperitoneal chemotherapy. After performing the surgical intervention, the patient will be irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Surgery and Intraperitoneal Chemotherapy Receives: Procedure: Experimental group |
| Control group | Placebo comparator | only surgery Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive peritoneal lavage
Cancer cell vitality
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start9 Jan 2018
- Primary completion5 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Achkasov Sergey, State Scientific Centre of Coloproctology, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561948
- Sponsor's protocol ID
- 13
- Status last verified
- Mar 2021
- First submitted
- 30 May 2018
- Last updated
- 19 Mar 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 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
- ClinicalTrials.gov ID
- NCT03561948
- Acronym / sponsor ID
- 13
- Conditions
- Colon Cancer
- Keywords
- intraperitoneal chemotherapy, Peritoneal Carcinomatosis, Colonic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 19 Jun 2018 (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.
This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.
Detailed description
In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. Patients of this group will not receive intraoperative intra-abdominal chemotherapy. After performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Experimental groupSurgery and Intraperitoneal Chemotherapy |
| Control group | Placebo comparator | Procedure: Control grouponly surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual:
- Histologically verified adenocarcinoma of the colon.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- The presence of synchronous or metachronous malignant tumors.
- Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs.
- Neoadjuvant chemotherapy.
- Suspected Lynch syndrome.
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 |
|---|---|---|
| Experimental groupAfter performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination. | Procedure or surgery | Experimental group |
| Control groupIn the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed with subsequent immunological examination. Patients of this group will not receive intraperitoneal chemotherapy. After performing the surgical intervention, the patient will be irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination. | Procedure or surgery | Control group |
Primary outcome
Positive peritoneal lavage
Time frame: through study completion, an average of 1 year
Cancer cell vitality
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 19 Mar 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.
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?
A study testing Experimental group in people with Colon Cancer, 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 3 inclusion and 5 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 19 Mar 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 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. Some participants in this study may receive a placebo. 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?
Positive peritoneal lavage (time frame: through study completion, an average of 1 year). 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 Mar 2021.