Colonic Neoplasms MalignantLoCCOSTeNCT06121089
Local Cecal Cancer - Optimization of Surgical Treatment
A study testing ileocecal resection with extended D3 lymphadenectomy. and Right hemicolectomy with D3 lymphadenectomy. in people with Colonic Neoplasms Malignant and Cecal Neoplasms, run by Moscow Clinical Scientific Center at 1 site in Russia.
Trial summary
The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms Malignant, Cecal Neoplasms
- What is being tested?
- ileocecal resection with extended D3 lymphadenectomy. and Right hemicolectomy with D3 lymphadenectomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- At least 18 years of age.
- ECOG status 0-2.
- Histologically confirmed adenocarcinoma of the colon.
- Clinical stage T1-3; N+; M0.
- The physical status from ASA classification I, II, III or IV.
- Written informed consent.
Who cannot join
- Synchronous or metachronous malignancy.
- Locally-advanced tumor (T>3).
- Presence of distant metastases (M1).
- Complicated tumor: obstruction, perforation.
- Neoadjuvant chemotherapy.
- Medical contraindications for surgical treatment.
- Pregnancy or breast feeding.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Moscow Clinical Scientific Center
Moscow
Igor Matveev, +7(916)182-17-46, i.matveev@mknc.ru
About this study
Official title: Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.
Read the detailed description
The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.
Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.
Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.
After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.
Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT > 3).
All patients will be randomly divided into two groups in a 1:1 ratio.
- Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis.
- Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.
Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.
- Conditions
- Colonic Neoplasms Malignant, Cecal Neoplasms
- Being tested
- ileocecal resection with extended D3 lymphadenectomy., Right hemicolectomy with D3 lymphadenectomy.
- Keywords
- Colorectal cancer, Segmental colonic resection, Ileocecal resection, Cecal cancer, Right hemicolectomy
- Medical subject headings
- Cecal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileocecal resection with extended D3 lymphadenectomy.Procedure or surgery
Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis.
Right hemicolectomy with D3 lymphadenectomy.Procedure or surgery
Laparoscopy right hemicolectomy with D3 lymphadenectomy including 201, 202, 203, 213, 211, 212, 221, 222-rt groups of lymph nodes. Manual double-row ileo-transverse-anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy ileocecal resection with extended D3 lymphadenectomy. | Active comparator | Ileocecal resection with extended D3 lymphadenectomy. Receives: Procedure: ileocecal resection with extended D3 lymphadenectomy. |
| Laparoscopy right hemicolectomy with D3 lymphadenectomy. | Experimental | Right hemicolectomy with D3 lymphadenectomy Receives: Procedure: Right hemicolectomy with D3 lymphadenectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival.
Overall survival of patients.
Measured: 5 years after the last patient.
Disease-free survival.
Survival without local or distant recurrence.
Measured: 3 years after the last patient.
Disease-free survival.
Survival without local or distant recurrence.
Measured: 5 years after the last patient.
Secondary outcomes (10)
Postoperative morbidity.
Complications after surgery.
Measured: The first 30 days after surgery.
Postoperative mortality.
Death after surgery.
Measured: The first 30 days after surgery.
Total number of lymph nodes removed.
Number of removed lymph nodes according to pathomorphological evaluation.
Measured: Post-intervention at week 3.
Total number of metastatic lymph nodes and correlation by group.
The ratio of affected lymph nodes into groups (201, 202, 203, 213, 211, 212, 221 or 222-rt) depending on the type of surgical treatment. Based on pathological assessment.
Measured: Post-intervention at week 3.
Total length of removed bowel.
Average length of removed bowel in both groups according to pathomorphological evaluation (millimeters).
Measured: Post-intervention at week 3.
Area of mesentery removed.
Average area of the removed mesentery in each groups according to pathomorphological evaluation (square centimetre - sq.cm).
Measured: Post-intervention at week 3.
Description of blood loss during the intraoperative period.
Average blood loss during surgery in each group (ml).
Measured: During the surgery.
Operation time.
Average operation time for each group (minutes - min).
Measured: Immediately after the surgery.
Conversion.
The total number of conversions for each group.
Measured: During the surgery.
Number of days of inpatient treatment.
Average number of days of inpatient treatment.
Measured: During hospitalization up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Sep 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Neoplasms MalignantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be randomly divided into two groups in a 1:1 ratio. 1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. 2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121089
- Sponsor's protocol ID
- 10/2022
- Acronym
- LoCCOSTe
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share personal patient data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
- ClinicalTrials.gov ID
- NCT06121089
- Acronym / sponsor ID
- LoCCOSTe / 10/2022
- Conditions
- Colonic Neoplasms Malignant, Cecal Neoplasms
- Keywords
- Colorectal cancer, Segmental colonic resection, Ileocecal resection, Cecal cancer, Right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Nov 2023 (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 purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.
Detailed description
The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.
Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.
Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.
After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.
Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT > 3).
All patients will be randomly divided into two groups in a 1:1 ratio.
- Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis.
- Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.
Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All patients will be randomly divided into two groups in a 1:1 ratio. 1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. 2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy ileocecal resection with extended D3 lymphadenectomy. | Active comparator | Procedure: ileocecal resection with extended D3 lymphadenectomy.Ileocecal resection with extended D3 lymphadenectomy. |
| Laparoscopy right hemicolectomy with D3 lymphadenectomy. | Experimental | Procedure: Right hemicolectomy with D3 lymphadenectomy.Right hemicolectomy with D3 lymphadenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age.
- ECOG status 0-2.
- Histologically confirmed adenocarcinoma of the colon.
- Clinical stage T1-3; N+; M0.
- The physical status from ASA classification I, II, III or IV.
Key exclusion criteria (8 listed)
- Synchronous or metachronous malignancy.
- Locally-advanced tumor (T>3).
- Presence of distant metastases (M1).
- Complicated tumor: obstruction, perforation.
- Neoadjuvant chemotherapy.
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 |
|---|---|---|
| ileocecal resection with extended D3 lymphadenectomy.Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis. | Procedure or surgery | Laparoscopy ileocecal resection with extended D3 lymphadenectomy. |
| Right hemicolectomy with D3 lymphadenectomy.Laparoscopy right hemicolectomy with D3 lymphadenectomy including 201, 202, 203, 213, 211, 212, 221, 222-rt groups of lymph nodes. Manual double-row ileo-transverse-anastomosis. | Procedure or surgery | Laparoscopy right hemicolectomy with D3 lymphadenectomy. |
Primary outcome
Overall survival.
Time frame: 5 years after the last patient.
Overall survival of patients.
Disease-free survival.
Time frame: 3 years after the last patient.
Survival without local or distant recurrence.
Disease-free survival.
Time frame: 5 years after the last patient.
Survival without local or distant recurrence.
10 secondary outcomes
Postoperative morbidity.
Time frame: The first 30 days after surgery.
Postoperative mortality.
Time frame: The first 30 days after surgery.
Total number of lymph nodes removed.
Time frame: Post-intervention at week 3.
Total number of metastatic lymph nodes and correlation by group.
Time frame: Post-intervention at week 3.
Total length of removed bowel.
Time frame: Post-intervention at week 3.
Area of mesentery removed.
Time frame: Post-intervention at week 3.
Description of blood loss during the intraoperative period.
Time frame: During the surgery.
Operation time.
Time frame: Immediately after the surgery.
Conversion.
Time frame: During the surgery.
Number of days of inpatient treatment.
Time frame: During hospitalization up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. We are not planning to share personal patient data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ileocecal resection with extended D3 lymphadenectomy. and Right hemicolectomy with D3 lymphadenectomy. in people with Colonic Neoplasms Malignant and Cecal Neoplasms, run by Moscow Clinical Scientific Center 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Matveev (+7(916)182-17-46, i.matveev@mknc.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. (time frame: 5 years after the last patient.). The study lists 3 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 18 Nov 2023.