Colorectal Neoplasms MalignantNCT05129774
Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
A study testing Radical surgery with PALND and Radical surgery without PALND in people with Colorectal Neoplasms Malignant and Lymph Node Excision, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Neoplasms Malignant, Lymph Node Excision, Chemoradiotherapy
- What is being tested?
- Radical surgery with PALND and Radical surgery without PALND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age at enrollment is ≥ 18 and ≤ 75 years
- ECOG PS 0-1
- histologically confirmed left-sided colon and rectal carcinoma
- synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
- patients potential to receive surgery and achieve no evidence of disease (NED)
- able to tolerate surgery
- providing written informed consent
Who cannot join
- local invasion or distant metastasis other than para-aoritc lymph nodes
- history of other malignant tumor
- coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
- emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiang Zhang, 18560089182, xiang.zhang02@hotmail.com
Yanlei Wang, 18560085128, yanleiwang@hotmail.com
About this study
Official title: Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis
- Being tested
- Radical surgery with PALND, Radical surgery without PALND
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical surgery with PALNDProcedure or surgery
sufficient resection margins of the tumor, D3 dissection of the regional lymph nodes and para-aortic lymph node dissection from the bifurcation of iliac artery to the left renal vein via laparoscopic approach
Radical surgery without PALNDProcedure or surgery
surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND
| Study group | Role | What they receive |
|---|---|---|
| radical surgery with PALND | Experimental | Not described Receives: Procedure: Radical surgery with PALND |
| radical surgery without PALND | Active comparator | Not described Receives: Procedure: Radical surgery without PALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year OS
5-year overall survival
Measured: From date of recruitment until the date of death from any cause, assessed up to 5 years
Secondary outcomes (3)
DFS
5-year disease-free survival
Measured: From date of recruitment until the date of disease recurrece, assessed up to 5 years
LFFS
Local failure free survival
Measured: From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
Postoperative complications
Postoperative complications
Measured: From date of surgery until the date of 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129774
- Sponsor's protocol ID
- V123456
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
- ClinicalTrials.gov ID
- NCT05129774
- Acronym / sponsor ID
- V123456
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Nov 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.
In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radical surgery with PALND | Experimental | Procedure: Radical surgery with PALND |
| radical surgery without PALND | Active comparator | Procedure: Radical surgery without PALND |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age at enrollment is ≥ 18 and ≤ 75 years
- ECOG PS 0-1
- histologically confirmed left-sided colon and rectal carcinoma
- synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
- patients potential to receive surgery and achieve no evidence of disease (NED)
Key exclusion criteria (4 listed)
- local invasion or distant metastasis other than para-aoritc lymph nodes
- history of other malignant tumor
- coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
- 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 |
|---|---|---|
| Radical surgery with PALNDsufficient resection margins of the tumor, D3 dissection of the regional lymph nodes and para-aortic lymph node dissection from the bifurcation of iliac artery to the left renal vein via laparoscopic approach | Procedure or surgery | radical surgery with PALND |
| Radical surgery without PALNDsurgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND | Procedure or surgery | radical surgery without PALND |
Primary outcome
5-year OS
Time frame: From date of recruitment until the date of death from any cause, assessed up to 5 years
5-year overall survival
3 secondary outcomes
DFS
Time frame: From date of recruitment until the date of disease recurrece, assessed up to 5 years
LFFS
Time frame: From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
Postoperative complications
Time frame: From date of surgery until the date of 30 days after surgery
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 22 Nov 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical surgery with PALND and Radical surgery without PALND in people with Colorectal Neoplasms Malignant and Lymph Node Excision, run by Qilu Hospital of Shandong University at 1 site in China.
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 7 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: opening soon, as of the sponsor's last update on 22 Nov 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 China. 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 Yong Dai, M.D. Ph.D. (+8618560085117, yongdai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year OS (time frame: From date of recruitment until the date of death from any cause, assessed up to 5 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 22 Nov 2021.