Synchronous Isolated Para-aortic Lymph Node MetastasisNCT04774757
Systemic Therapy Sequenced Isolated PALND for mCRC
A study testing Para-aortic lymph node dissection in people with Synchronous Isolated Para-aortic Lymph Node Metastasis and Colorectal Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Synchronous Isolated Para-aortic Lymph Node Metastasis, Colorectal Cancer
- What is being tested?
- Para-aortic lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2021to 1 Mar 2026
- 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 75 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 colorectal carcinoma
- Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape.
- Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
- Adequate liver, renal and bona marrow function.
- Signing written informed consent
Who cannot join
- In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis.
- Unable to achieve NED
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months.
- Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- Organ transplantation requires immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Guosheng Wu, M.D., +8617857310313, guosheng_wu@zju.edu.cn
About this study
Official title: Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.
Read the detailed description
Patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by MDT that are potential to reach no evidence of disease (NED) were included in our trial. All included patients receive para-aortic lymph node dissection.
- Being tested
- Para-aortic lymph node dissection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-aortic lymph node dissectionProcedure or surgery
Para-aortic lymph node dissection was defined as the dissection of para-aortic lymph nodes located below renal vein and above the bifurcation of iliac artery.
| Study group | Role | What they receive |
|---|---|---|
| Systemic therapy sequenced PALND | Experimental | All received systemtic therapy (at most two lines). Receives: Procedure: Para-aortic lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year DFS
Time with no recurrence of the diseases.
Measured: From date of recruiment until the date of disease recurrece, assessed up to 3 years
Secondary outcomes (3)
5-year OS
From date of recruitment until the date of death from any cause, assessed up to 5 years.
Measured: Up to 5 years
LFS
Time with no recurrence of the paraaortic lymph node region.
Measured: From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years
1-year DFS
Time with no recurrence of the diseases.
Measured: From date of recruiment until the date of disease recurrece, assessed up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start10 Mar 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synchronous Isolated Para-aortic Lymph Node MetastasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guosheng Wu, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774757
- Sponsor's protocol ID
- Synchronous isolated PALND
- Status last verified
- Oct 2021
- First submitted
- 25 Feb 2021
- Last updated
- 11 Oct 2021
- Results posted
- 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04774757
- Acronym / sponsor ID
- Synchronous isolated PALND
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Mar 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.
The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.
Detailed description
Patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by MDT that are potential to reach no evidence of disease (NED) were included in our trial. All included patients receive para-aortic lymph node dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic therapy sequenced PALND | Experimental | Procedure: Para-aortic lymph node dissectionAll received systemtic therapy (at most two lines). |
Who may qualify
- Ages
- 18 to 75 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 colorectal carcinoma
- Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape.
- Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
Key exclusion criteria (5 listed)
- In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis.
- Unable to achieve NED
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months.
- Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- Organ transplantation requires immunosuppressive therapy
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 |
|---|---|---|
| Para-aortic lymph node dissectionPara-aortic lymph node dissection was defined as the dissection of para-aortic lymph nodes located below renal vein and above the bifurcation of iliac artery. | Procedure or surgery | Systemic therapy sequenced PALND |
Primary outcome
3-year DFS
Time frame: From date of recruiment until the date of disease recurrece, assessed up to 3 years
Time with no recurrence of the diseases.
3 secondary outcomes
5-year OS
Time frame: Up to 5 years
LFS
Time frame: From date of recruiment until the date of paraaortic lymph node recurrece, assessed up to 5 years
1-year DFS
Time frame: From date of recruiment until the date of disease recurrece, assessed up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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?
A study testing Para-aortic lymph node dissection in people with Synchronous Isolated Para-aortic Lymph Node Metastasis and Colorectal Cancer, run by First Affiliated Hospital of Zhejiang 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 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: status not confirmed, as of the sponsor's last update on 11 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guosheng Wu, MD (+8617857310313, guosheng_wu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS (time frame: From date of recruiment until the date of disease recurrece, assessed up to 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 Oct 2021.