Pancreatic CancerPhase 3NCT03398291
Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
A Phase 3 study testing Synchronous resection of primary pancreatic cancer and liver oligometastasis and Standard chemotherapy in people with Pancreatic Cancer and Liver Metastases, run by Fudan University at 1 site in China.
Trial summary
This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Liver Metastases, Surgery
- What is being tested?
- Synchronous resection of primary pancreatic cancer and liver oligometastasis and Standard chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Jun 2025
- 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
- Voluntary participation
- 18-75 years old
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Stage IV pancreatic cancer with no more than 3 liver metastases
- Histologically confirmed diagnosis of pancreatic cancer
- No contraindication of chemotherapy
Show all 9Show fewer
- Primary tumor and liver metastatic sites are both resectable.
- No new metastatic sites were observed
- Abnormal serum tumor maker levels decreased by more than 50% after chemotherapy. In the serum tumor makers, carbohydrate antigen 19-9 (CA19-9) was always the first choice for evaluation and it should be below 500U/L after treatment. However, when the baseline CA19-9 was within the normal range, carbohydrate antigen 125 (CA125) and carcinoembryonic antigen (CEA) were the alternative candidate indicators.
Who cannot join
- Not want to receive chemotherapy or potential operation.
- Metastases at other sites except for liver
- With other malignancies
- Receive chemotherapy, radiotherapy, and interventional therapy before
- Contraindication of potential operation
- 1. Contraindication of operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
XianJun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Si Shi, M.D., +86-21-6417-5590, shisi@fudanpci.org
About this study
This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Half of participants who meet the entry criterion will receive surgical intervention, while the other half will continue to receive standard chemotherapy.
- Conditions
- Pancreatic Cancer, Liver Metastases, Surgery
- Being tested
- Synchronous resection of primary pancreatic cancer and liver oligometastasis, Standard chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous resection of primary pancreatic cancer and liver oligometastasisProcedure or surgery
Patients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is recommended to be based on the preoperative chemotherapy.
Standard chemotherapyDrug
Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Patients continue to receive standard chemotherapy. Receives: Drug: Standard chemotherapy |
| Surgical exploration | Experimental | Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed. Receives: Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real overall survival
Including the time of induction chemotherapy
Measured: Up to 2 years
Secondary outcomes (4)
Overall survival
Not including the time of induction chemotherapy
Measured: Up to 2 years
Life quality score
Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Measured: Up to 2 years, every 2 months
Postoperative morbidity
Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation
Measured: Up to 90 days after operation
Postoperative mortality
Patients die from any cause during 90 days after operation
Measured: Up to 90 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Jul 2018
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398291
- Sponsor's protocol ID
- CSPAC-1
- Status last verified
- Oct 2018
- First submitted
- 1 Jan 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michalski CW, Erkan M, Huser N, Muller MW, Hartel M, Friess H, Kleeff J. Resection of primary pancreatic cancer and liver metastasis: a systematic review. Dig Surg. 2008;25(6):473-80. doi: 10.1159/000184739. Epub 2009 Feb 12.
PubMed 19212120Cannistra' M, Ruggiero M, Zullo A, Grande R, Nardo B. Surgical resection of synchronous and metachronous metastases from pancreatic adenocarcinoma. Two case reports in the light of recent evidences. Ann Ital Chir. 2015 Dec 29;86(ePub):S2239253X15024160.
PubMed 26754676Buc E, Orry D, Antomarchi O, Gagniere J, Da Ines D, Pezet D. Resection of pancreatic ductal adenocarcinoma with synchronous distant metastasis: is it worthwhile? World J Surg Oncol. 2014 Nov 18;12:347. doi: 10.1186/1477-7819-12-347.
PubMed 25407113Zanini N, Lombardi R, Masetti M, Giordano M, Landolfo G, Jovine E. Surgery for isolated liver metastases from pancreatic cancer. Updates Surg. 2015 Mar;67(1):19-25. doi: 10.1007/s13304-015-0283-6. Epub 2015 Feb 22.
PubMed 25702263Tachezy M, Gebauer F, Janot M, Uhl W, Zerbi A, Montorsi M, Perinel J, Adham M, Dervenis C, Agalianos C, Malleo G, Maggino L, Stein A, Izbicki JR, Bockhorn M. Synchronous resections of hepatic oligometastatic pancreatic cancer: Disputing a principle in a time of safe pancreatic operations in a retrospective multicenter analysis. Surgery. 2016 Jul;160(1):136-144. doi: 10.1016/j.surg.2016.02.019. Epub 2016 Apr 3.
PubMed 27048934Wei M, Shi S, Hua J, Xu J, Yu X; Chinese Study Group for Pancreatic Cancer (CSPAC). Simultaneous resection of the primary tumour and liver metastases after conversion chemotherapy versus standard therapy in pancreatic cancer with liver oligometastasis: protocol of a multicentre, prospective, randomised phase III control trial (CSPAC-1). BMJ Open. 2019 Dec 8;9(12):e033452. doi: 10.1136/bmjopen-2019-033452.
PubMed 31818843
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT03398291
- Acronym / sponsor ID
- CSPAC-1
- Conditions
- Pancreatic Cancer, Liver Metastases, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Jan 2018 (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.
This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Half of participants who meet the entry criterion will receive surgical intervention, while the other half will continue to receive standard chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Drug: Standard chemotherapyPatients continue to receive standard chemotherapy. |
| Surgical exploration | Experimental | Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasisPatients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation
- 18-75 years old
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Stage IV pancreatic cancer with no more than 3 liver metastases
- Histologically confirmed diagnosis of pancreatic cancer
Key exclusion criteria (6 listed)
- Not want to receive chemotherapy or potential operation.
- Metastases at other sites except for liver
- With other malignancies
- Receive chemotherapy, radiotherapy, and interventional therapy before
- Contraindication of potential operation
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 |
|---|---|---|
| Synchronous resection of primary pancreatic cancer and liver oligometastasisPatients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is recommended to be based on the preoperative chemotherapy. | Procedure or surgery | Surgical exploration |
| Standard chemotherapyPatients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1 | Drug | Standard treatment |
Primary outcome
Real overall survival
Time frame: Up to 2 years
Including the time of induction chemotherapy
4 secondary outcomes
Overall survival
Time frame: Up to 2 years
Life quality score
Time frame: Up to 2 years, every 2 months
Postoperative morbidity
Time frame: Up to 90 days after operation
Postoperative mortality
Time frame: Up to 90 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Background: PubMed 19212120Michalski CW, Erkan M, Huser N, Muller MW, Hartel M, Friess H, Kleeff J. Resection of primary pancreatic cancer and liver metastasis: a systematic review. Dig Surg. 2008;25(6):473-80. doi: 10.1159/000184739. Epub 2009 Feb 12.
- Background: PubMed 26754676Cannistra' M, Ruggiero M, Zullo A, Grande R, Nardo B. Surgical resection of synchronous and metachronous metastases from pancreatic adenocarcinoma. Two case reports in the light of recent evidences. Ann Ital Chir. 2015 Dec 29;86(ePub):S2239253X15024160.
- Background: PubMed 25407113Buc E, Orry D, Antomarchi O, Gagniere J, Da Ines D, Pezet D. Resection of pancreatic ductal adenocarcinoma with synchronous distant metastasis: is it worthwhile? World J Surg Oncol. 2014 Nov 18;12:347. doi: 10.1186/1477-7819-12-347.
- Background: PubMed 25702263Zanini N, Lombardi R, Masetti M, Giordano M, Landolfo G, Jovine E. Surgery for isolated liver metastases from pancreatic cancer. Updates Surg. 2015 Mar;67(1):19-25. doi: 10.1007/s13304-015-0283-6. Epub 2015 Feb 22.
- Background: PubMed 27048934Tachezy M, Gebauer F, Janot M, Uhl W, Zerbi A, Montorsi M, Perinel J, Adham M, Dervenis C, Agalianos C, Malleo G, Maggino L, Stein A, Izbicki JR, Bockhorn M. Synchronous resections of hepatic oligometastatic pancreatic cancer: Disputing a principle in a time of safe pancreatic operations in a retrospective multicenter analysis. Surgery. 2016 Jul;160(1):136-144. doi: 10.1016/j.surg.2016.02.019. Epub 2016 Apr 3.
- Derived from this study: PubMed 31818843Wei M, Shi S, Hua J, Xu J, Yu X; Chinese Study Group for Pancreatic Cancer (CSPAC). Simultaneous resection of the primary tumour and liver metastases after conversion chemotherapy versus standard therapy in pancreatic cancer with liver oligometastasis: protocol of a multicentre, prospective, randomised phase III control trial (CSPAC-1). BMJ Open. 2019 Dec 8;9(12):e033452. doi: 10.1136/bmjopen-2019-033452.
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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 3 study testing Synchronous resection of primary pancreatic cancer and liver oligometastasis and Standard chemotherapy in people with Pancreatic Cancer and Liver Metastases, 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 9 inclusion and 6 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 9 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, M.D., Ph.D. (+86-21-64175590 ext. 1307, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real overall survival (time frame: Up to 2 years). 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 NCT03398291, which also lists 6 linked publications.
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 9 Oct 2018.