Colorectal NeoplasmsPhase 3NCT01307878
New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases
A Phase 3 study testing chemotherapy ± targeted therapy in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Fudan University at 1 site in China.
Trial summary
To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms
- What is being tested?
- chemotherapy ± targeted therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 2021
- Phase
- Phase 3
- 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 between 18 - 75 years old
- colorectal adenocarcinoma pathologically
- without any chemotherapy or radiotherapy
- unresectable liver metastasis and without other metastasis
- resectable colorectal cancer
- suitable for chemotherapy
- agreed by patients
Who cannot join
- age below 18 years old or greater than 75 years old
- haven't pathological diagnosis of colorectal adenocarcinoma
- with any chemotherapy or radiotherapy
- resectable liver metastasis or without other metastasis
- unresectable colorectal cancer
- unsuitable for chemotherapy
- not agreed by patients
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan hospital, Fudan university
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases
To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.
Read the detailed description
Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Chemotherapy; Maternal, Affecting Fetus
- Being tested
- chemotherapy ± targeted therapy
- Keywords
- Unresectable colorectal liver metastases, Pre-operation chemotherapy, Primary tumor resection, Survival
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy ± targeted therapyDrug
Also called chemotherapy plus targeted therapy
Chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
| Study group | Role | What they receive |
|---|---|---|
| arm A | Experimental | Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability. Receives: Drug: chemotherapy ± targeted therapy |
| arm B | No intervention | Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from randomization to the date of disease progression or to death of any cause
Measured: Up to 3 years
Secondary outcomes (5)
Overall survival
Time from randomization to death from any cause or the date of the last follow-up
Measured: Up to 3 years
Tumor response
Response according to RECIST 1.1
Measured: Up to 6 months
Secondary resection rate Second radical resectability
The rate of patients converted to resection for liver metastases
Measured: Up to 6 months
Surgical complications
The proportion of patients with any complications occurred within 30 days after surgery
Measured: 30 days after surgery
Toxicity of chemotherapy
Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startJun 2012
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Ruijin Hospital, Changhai Hospital
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, Ph.D., M.D, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307878
- Sponsor's protocol ID
- RECUT
- Status last verified
- Jun 2022
- First submitted
- 2 Mar 2011
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases
- ClinicalTrials.gov ID
- NCT01307878
- Acronym / sponsor ID
- RECUT
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Chemotherapy; Maternal, Affecting Fetus
- Keywords
- Unresectable colorectal liver metastases, Pre-operation chemotherapy, Primary tumor resection, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Ruijin Hospital, Changhai Hospital
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 3 Mar 2011 (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.
To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.
Detailed description
Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm A | Experimental | Drug: chemotherapy ± targeted therapyPre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability. |
| arm B | No intervention | –Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability. |
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 between 18 - 75 years old
- colorectal adenocarcinoma pathologically
- without any chemotherapy or radiotherapy
- unresectable liver metastasis and without other metastasis
- resectable colorectal cancer
Key exclusion criteria (7 listed)
- age below 18 years old or greater than 75 years old
- haven't pathological diagnosis of colorectal adenocarcinoma
- with any chemotherapy or radiotherapy
- resectable liver metastasis or without other metastasis
- unresectable colorectal cancer
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 |
|---|---|---|
| chemotherapy ± targeted therapyAlso: chemotherapy plus targeted therapyChemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability. | Drug | arm A |
Primary outcome
Progression-free survival
Time frame: Up to 3 years
Time from randomization to the date of disease progression or to death of any cause
5 secondary outcomes
Overall survival
Time frame: Up to 3 years
Tumor response
Time frame: Up to 6 months
Secondary resection rate Second radical resectability
Time frame: Up to 6 months
Surgical complications
Time frame: 30 days after surgery
Toxicity of chemotherapy
Time frame: Up to 6 months
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 14 Jun 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, Ph.D., M.D study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chemotherapy ± targeted therapy in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Fudan 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 7 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 14 Jun 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression-free survival (time frame: 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 14 Jun 2022.