Colorectal CancerPhase 2NCT00594529
Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
A Phase 2 study testing Surgery in people with Colorectal Cancer and Liver Metastasis, run by Kyoto University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2008to May 2013
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
- Liver lesions are measurable by spiral CT or SPIO-MRI scans.
- Extrahepatic lesions include lung metastases which can be resected curatively.
- Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
- No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
- No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
- Performance status (ECOG): 0-1
- Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
Who cannot join
- Excluded are cases with conditions as below:
- Peritoneal or pleural fluid retention to be drained.
- Multiple malignancies to be treated.
- Peripheral neural disturbances.
- Active infectious diseases.
- Severe watery diarrhea.
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- Mental disturbances.
- Treatment history of continuous, oral or intravenous steroid therapy.
- Previous history of ischemic heart diseases.
- Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
- Pregnant.
- Previous history of severe drug-induced allergy.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
Satoshi Nagayama, Assistant, +81-75-751-3227, nagayama@kuhp.kyoto-u.ac.jp
About this study
The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.
- Conditions
- Colorectal Cancer, Liver Metastasis
- Being tested
- Surgery
- Keywords
- Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Liver resection for metastatic liver lesions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curative resection rates of liver metastases
Measured: 2 years after the operations
Secondary outcomes (1)
Completion rates of neoadjuvant chemotherapy
Measured: 2 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594529
- Sponsor's protocol ID
- C-206
- Other IDs
- UMIN000000961
- Status last verified
- Aug 2009
- First submitted
- 4 Jan 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
Publications
Nagayama S, Hasegawa S, Hida K, Kawada K, Hatano E, Nakamura K, Seo S, Taura K, Yasuchika K, Matsuo T, Zaima M, Kanazawa A, Terajima H, Tada M, Adachi Y, Nishitai R, Manaka D, Yoshimura T, Doi K, Horimatsu T, Mitsuyoshi A, Yoshimura K, Niimi M, Matsumoto S, Sakai Y, Uemoto S. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol. 2017 Apr;22(2):316-323. doi: 10.1007/s10147-016-1050-5. Epub 2016 Oct 17.
PubMed 27752787
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
- ClinicalTrials.gov ID
- NCT00594529
- Acronym / sponsor ID
- C-206
- Conditions
- Colorectal Cancer, Liver Metastasis
- Keywords
- Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2013 (estimated)
- First posted
- 15 Jan 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 evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
- Liver lesions are measurable by spiral CT or SPIO-MRI scans.
- Extrahepatic lesions include lung metastases which can be resected curatively.
- Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
- No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
Key exclusion criteria (12 listed)
- Peritoneal or pleural fluid retention to be drained.
- Multiple malignancies to be treated.
- Peripheral neural disturbances.
- Active infectious diseases.
- Severe watery diarrhea.
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 |
|---|---|---|
| SurgeryLiver resection for metastatic liver lesions | Procedure or surgery | 1 |
Primary outcome
Curative resection rates of liver metastases
Time frame: 2 years after the operations
1 secondary outcome
Completion rates of neoadjuvant chemotherapy
Time frame: 2 years after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Derived from this study: PubMed 27752787Nagayama S, Hasegawa S, Hida K, Kawada K, Hatano E, Nakamura K, Seo S, Taura K, Yasuchika K, Matsuo T, Zaima M, Kanazawa A, Terajima H, Tada M, Adachi Y, Nishitai R, Manaka D, Yoshimura T, Doi K, Horimatsu T, Mitsuyoshi A, Yoshimura K, Niimi M, Matsumoto S, Sakai Y, Uemoto S. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol. 2017 Apr;22(2):316-323. doi: 10.1007/s10147-016-1050-5. Epub 2016 Oct 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery in people with Colorectal Cancer and Liver Metastasis, run by Kyoto University at 1 site in Japan.
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 8 inclusion and 12 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 23 Jun 2011. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Satoshi Nagayama, Assistant (+81-75-751-3227, nagayama@kuhp.kyoto-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curative resection rates of liver metastases (time frame: 2 years after the operations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594529, which also lists 1 linked publication.
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 23 Jun 2011.