Rectal Neoplasm With Metastasis to the LiverNCT00677586
Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis
A study testing simultaneous resection of liver metastasis and the rectal primary tumor and staged resection of liver metastasis and the rectal primary tumor in people with Rectal Neoplasm With Metastasis to the Liver, run by Fudan University.
Trial summary
The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasm With Metastasis to the Liver
- What is being tested?
- simultaneous resection of liver metastasis and the rectal primary tumor and staged resection of liver metastasis and the rectal primary tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to 1 Jul 2022
- 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>=18 and <= 75 years
- resectable primary rectal tumor
- remnant liver volume >= 60%
- without other organ metastasis or peritoneum metastasis
- without contradiction of cardiac and pulmonary diseases
- American Society of Anesthesiologists (ASA) class I - II
- Histologically proved rectal adenocarcinoma
Who cannot join
- age > 75 years
- unresectable primary rectal tumor
- remnant liver volume < 60%
- with other organ metastasis or peritoneum metastasis
- with contradiction of cardiac and pulmonary diseases
- Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy
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- Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- Multiple colorectal tumors or other schedules needing for synchronous colon surgery
- Co-existent inflammatory bowel disease
- Pregnancy or lactation
- Patients received treatment other than preoperative radio- or chemoradiotherapy
About this study
Official title: Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial
The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.
Read the detailed description
The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.
- Being tested
- simultaneous resection of liver metastasis and the rectal primary tumor, staged resection of liver metastasis and the rectal primary tumor
- Keywords
- rectal neoplasms, liver metastasis, surgery, simultaneous resection, staged resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous resection of liver metastasis and the rectal primary tumorProcedure or surgery
simultaneous resection of liver metastasis and the rectal primary tumor
staged resection of liver metastasis and the rectal primary tumorProcedure or surgery
Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | simultaneous resection of liver metastasis and the rectal primary tumor Receives: Procedure: simultaneous resection of liver metastasis and the rectal primary tumor |
| 2 | Active comparator | staged resection of the liver metastasis and the rectal primary tumor Receives: Procedure: staged resection of liver metastasis and the rectal primary tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complication rate after resection of primary and metastatic lesions
Grade of III-V complication rate according to Clavien-Dindo
Measured: 30 days after surgery
Secondary outcomes (6)
Disease free survival
Disease free survival after the last resection of primary and metastatic lesions
Measured: 3 years
Overall survival
Overall survival after the last resection of primary and metastatic lesions
Measured: 3 years
Post-operative mortality
any death occured within 90 days after the last resection of primary and metastatic lesions
Measured: 90 days after surgery
Cost of hospitalization
any cost during the resection of primary and metastatic lesions
Measured: 2 months
Complication rate after resection of primary and metastatic lesions
All grade of complication rate according to Clavien-Dindo
Measured: 30 days after surgery
Postoperative hospital stay
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge
Measured: 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 posted14 May 2008 (estimated)
- Study startJul 2010
- Primary completion31 Dec 2020
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neoplasm With Metastasis to the LiverStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Parallel groups
- Model description
- Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- jianmin xu, MD, PHD, Study director, department of general surgery, zhongshan hospital, fudan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677586
- Sponsor's protocol ID
- RESONANCE
- Status last verified
- Jul 2022
- First submitted
- 12 May 2008
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00677586
- Acronym / sponsor ID
- RESONANCE
- Keywords
- rectal neoplasms, liver metastasis, surgery, simultaneous resection, staged resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 May 2008 (estimated)
- 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 investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.
Detailed description
The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: simultaneous resection of liver metastasis and the rectal primary tumorsimultaneous resection of liver metastasis and the rectal primary tumor |
| 2 | Active comparator | Procedure: staged resection of liver metastasis and the rectal primary tumorstaged resection of the liver metastasis and the rectal primary tumor |
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>=18 and <= 75 years
- resectable primary rectal tumor
- remnant liver volume >= 60%
- without other organ metastasis or peritoneum metastasis
- without contradiction of cardiac and pulmonary diseases
Key exclusion criteria (11 listed)
- age > 75 years
- unresectable primary rectal tumor
- remnant liver volume < 60%
- with other organ metastasis or peritoneum metastasis
- with contradiction of cardiac and pulmonary diseases
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 |
|---|---|---|
| simultaneous resection of liver metastasis and the rectal primary tumorsimultaneous resection of liver metastasis and the rectal primary tumor | Procedure or surgery | 1 |
| staged resection of liver metastasis and the rectal primary tumorPatients received resection of the rectal tumor. 1 months later received resection of liver metastasis | Procedure or surgery | 2 |
Primary outcome
Severe complication rate after resection of primary and metastatic lesions
Time frame: 30 days after surgery
Grade of III-V complication rate according to Clavien-Dindo
6 secondary outcomes
Disease free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Post-operative mortality
Time frame: 90 days after surgery
Cost of hospitalization
Time frame: 2 months
Complication rate after resection of primary and metastatic lesions
Time frame: 30 days after surgery
Postoperative hospital stay
Time frame: 30 days after surgery
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 7 Jul 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.
jianmin xu, MD, PHD study director
department of general surgery, zhongshan hospital, fudan university
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous resection of liver metastasis and the rectal primary tumor and staged resection of liver metastasis and the rectal primary tumor in people with Rectal Neoplasm With Metastasis to the Liver, run by Fudan University.
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 11 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Severe complication rate after resection of primary and metastatic lesions (time frame: 30 days after surgery). 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 7 Jul 2022.