Pancreatic Cancer ResectablePhase 3LEFT-PANCNCT07155629
Neoadjuvant Treatment vs Upfront Surgery for Left-Sided Pancreatic Cancer
A Phase 3 study testing mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine in people with Pancreatic Cancer Resectable, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
Pancreatic cancer is one of the most treatment resistant malignancies, often diagnosed at a late stage and associated with poor survival. The 5-year overall survival rate remains around 10%. Prognosis is affected by multiple factors including tumor stage, biology, treatment response, and anatomical location. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Sep 2025to 31 Aug 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable left pancreatic cancer according to NCCN criteria
- Written and informed consent
- Age > 18y
- ECOG 0-2
- Fit for surgery
- Fit for neoadjuvant chemotherapy
Who cannot join
- ECOG > 2
- Histology other than ductal adenocarcinoma
- Unable to give written consent
- < 18y
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites
Helsinki University Central Hospital
Helsinki, 00290
Hanna Seppänen, Adj. Prof., Pancreatic surgeon, +358-50-4270042, hanna.seppanen@hus.fi
Hanna Seppänen, Adj. Prof., Pancreatic surgeon
Oulu University Hospital
Oulu, 90220
Minna Nortunen, PhD, gastrointestinal surgeon, +358-8-3152875, minna.nortunen@pohde.fi
About this study
Official title: Neoadjuvant Treatment vs Upfront Surgery for Left Sided Pancreatic Cancer (LEFT-PANC) - a Study Protocol for a Prospective Randomized Multicenter Trial
Pancreatic cancer is one of the most treatment resistant malignancies, often diagnosed at a late stage and associated with poor survival. The 5-year overall survival rate remains around 10%. Prognosis is affected by multiple factors including tumor stage, biology, treatment response, and anatomical location. Distal (left-sided) pancreatic cancer, originating from the body or tail of the pancreas, accounts for approximately 20-25% of all pancreatic cancers and has been associated with worse survival than pancreatic head cancer, even when adjusted for stage. This may be due to histological, molecular, and embryological differences, and varied systemic therapy responses.
Neoadjuvant chemotherapy has become increasingly important in managing pancreatic cancer. It may improve outcomes by reducing tumor size, allowing for more complete (R0) resections, treating micrometastatic disease early, and identifying patients unlikely to benefit from surgery. While neoadjuvant therapy is recommended for borderline resectable and locally advanced tumors, randomized trials have not shown benefit for patients with upfront resectable pancreatic head cancer. Importantly, no randomized controlled trials have investigated the benefit of neoadjuvant treatment specifically in patients with upfront resectable left-sided pancreatic cancer, despite its distinct biology and worse prognosis.
Read more
Retrospective data suggest neoadjuvant therapy may improve survival in left-sided tumors. A recent multicenter study reported significantly longer overall survival in patients treated with neoadjuvant therapy compared to upfront surgery alone. However, prospective randomized data are lacking.
This multicenter randomized trial aims to assess whether patients with resectable left-sided pancreatic cancer benefit from neoadjuvant chemotherapy compared to upfront surgery. The study will reflect real-world clinical practice by allowing both commonly used regimens-FOLFIRINOX and Gemcitaine-Nab-paclitaxel -as neoadjuvant options. Previous studies have shown these regimens to be similarly effective, and switching between them due to toxicity or progression is feasible and does not seem to impair surgical outcomes or survival. This study aims to evaluate the benefits of neoadjuvant chemotherapy before surgery in a prospective multicenter randomized setting for resectable left-sided pancreatic cancer patients.
Read the detailed description
This is a multicenter, open-label, randomized phase III trial evaluating whether neoadjuvant chemotherapy improves overall survival in patients with resectable left-sided (body/tail) pancreatic cancer compared to the current standard of upfront surgery followed by adjuvant chemotherapy.
Eligible patients have histologically confirmed pancreatic adenocarcinoma located in the body or tail of the pancreas, ECOG/WHO performance status 0-2, and radiologically resectable disease according to NCCN criteria. Patients are randomized 1:1 to receive either:
- neoadjuvant chemotherapy, followed by surgery and adjuvant therapy, or
- upfront surgery followed by adjuvant chemotherapy.
Randomization uses a minimization method with stratification by performance status, CA19-9 level, treatment center, and chemotherapy regimen. Surgery is scheduled within 4-6 weeks of randomization (control arm) or after the last neoadjuvant cycle (intervention arm). Left pancreatectomy (open or minimally invasive) with standard lymphadenectomy and splenectomy is performed with complications reported using Dindo/Clavien classification and ISGPS criteria. Radical antegrade posterior pancreatosplenectomy may be performed when needed to ensure clear margins. Tumor response to neoadjuvant therapy will be evaluated by standardized histopathological grading.
Patients are followed with laboratory tests and CT imaging at the completion of adjuvant therapy and every six months thereafter until disease recurrence or up to five years after surgery. Quality of life is assessed at baseline, pre-surgery (in the neoadjuvant arm), 4 weeks post-op, and during follow-up using the EORTC QLQ-C30 and PAN26 instruments. Patients are followed for recurrence and survival every 6 months for up to 5 years. Safety is monitored per CTCAE v5.0, with SAEs and SUSARs reported per regulatory guidelines. An independent DSMB will review safety data. Blood and tumor samples will be stored for future translational research.
The primary endpoint is overall survival. A total of 381 patients will be enrolled over 36 months. The trial is powered to detect a hazard ratio of 0.70 with 80% power and a 5% significance level, requiring 247 events (deaths). Analysis will follow the intention-to-treat principle using Kaplan-Meier, log-rank test, and Cox regression. Pre-specified subgroup analyses will assess factors such as age, performance status, CA19-9, and tumor characteristics.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabineDrug
Also called oxaliplatin, irinotecan, leucovorin, 5-fluorouracil
The benefits of neoadjuvant chemotherapy before surgery in a prospective multicenter randomized setting for resectable left-sided pancreatic cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative chemotherapy | Experimental | Patients who undergo surgical resection will receive adjuvant chemotherapy with 4 cycles (2 months) of FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and 5-fluorouracil (400 mg/m2 bolus then 2400 mg/m2 over 46 h)) OR 2 cycles (2 months) of Gemcitabine 1000 mg/m2 over 30 min at day 1, 8, 15 of each 28-day cycle and capecitabine 830 mg/m2 ×2 daily for 3 weeks and one week rest of each 28-day cycle. Regimen changes due to toxicity are allowed.
After 2 and 4 months of NAT, response imaging (multiphased body CT) is assessed at a local pancreatic MDT. If stable disease or regression is observed, patients will undergo surgery after chemotherapy break of 3-6 weeks. Adjuvant chemotherapy (2-4 months) must be started within 4-12 weeks after resection. Dose adjustments follow local practice; adjuvant therapy depends on patient condition (mFOLFIRINOX, Gem+capecitabine, or gemcitabine alone). Receives: Drug: mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine |
| Control arm | No intervention | After randomization, arm B patients are scheduled for upfront surgery. Adjuvant chemotherapy of 6 months must be started within 4-12 weeks after resection. Dose reduction or dose delays are acted upon according to local clinical practice at each centre. The adjuvant therapy is decided and if necessary modified according to patient's condition (mFOLFIRINOX, Gem+cabecitabine, single Gem). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival of participants, defined as the time from randomization until death from any cause, analyzed in the intention-to-treat (ITT) population.
Measured: From randomization until death or study completion, up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- 381 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Hanna Seppänen, Helsinki University Central Hospital
- Investigators
- Hanna Seppänen, Adj. Prof., Pancreatic surgeon, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155629
- Sponsor's protocol ID
- HUS-LeftPanc-2025
- Acronym
- LEFT-PANC
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment vs Upfront Surgery for Left Sided Pancreatic Cancer (LEFT-PANC) - a Study Protocol for a Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT07155629
- Acronym / sponsor ID
- LEFT-PANC / HUS-LeftPanc-2025
- Conditions
- Pancreatic Cancer Resectable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 4 Sep 2025 (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.
Pancreatic cancer is one of the most treatment resistant malignancies, often diagnosed at a late stage and associated with poor survival. The 5-year overall survival rate remains around 10%. Prognosis is affected by multiple factors including tumor stage, biology, treatment response, and anatomical location. Distal (left-sided) pancreatic cancer, originating from the body or tail of the pancreas, accounts for approximately 20-25% of all pancreatic cancers and has been associated with worse survival than pancreatic head cancer, even when adjusted for stage. This may be due to histological, molecular, and embryological differences, and varied systemic therapy responses.
Neoadjuvant chemotherapy has become increasingly important in managing pancreatic cancer. It may improve outcomes by reducing tumor size, allowing for more complete (R0) resections, treating micrometastatic disease early, and identifying patients unlikely to benefit from surgery. While neoadjuvant therapy is recommended for borderline resectable and locally advanced tumors, randomized trials have not shown benefit for patients with upfront resectable pancreatic head cancer. Importantly, no randomized controlled trials have investigated the benefit of neoadjuvant treatment specifically in patients with upfront resectable left-sided pancreatic cancer, despite its distinct biology and worse prognosis.
Retrospective data suggest neoadjuvant therapy may improve survival in left-sided tumors. A recent multicenter study reported significantly longer overall survival in patients treated with neoadjuvant therapy compared to upfront surgery alone. However, prospective randomized data are lacking.
This multicenter randomized trial aims to assess whether patients with resectable left-sided pancreatic cancer benefit from neoadjuvant chemotherapy compared to upfront surgery. The study will reflect real-world clinical practice by allowing both commonly used regimens-FOLFIRINOX and Gemcitaine-Nab-paclitaxel -as neoadjuvant options. Previous studies have shown these regimens to be similarly effective, and switching between them due to toxicity or progression is feasible and does not seem to impair surgical outcomes or survival. This study aims to evaluate the benefits of neoadjuvant chemotherapy before surgery in a prospective multicenter randomized setting for resectable left-sided pancreatic cancer patients.
Detailed description
This is a multicenter, open-label, randomized phase III trial evaluating whether neoadjuvant chemotherapy improves overall survival in patients with resectable left-sided (body/tail) pancreatic cancer compared to the current standard of upfront surgery followed by adjuvant chemotherapy.
Eligible patients have histologically confirmed pancreatic adenocarcinoma located in the body or tail of the pancreas, ECOG/WHO performance status 0-2, and radiologically resectable disease according to NCCN criteria. Patients are randomized 1:1 to receive either:
- neoadjuvant chemotherapy, followed by surgery and adjuvant therapy, or
- upfront surgery followed by adjuvant chemotherapy.
Randomization uses a minimization method with stratification by performance status, CA19-9 level, treatment center, and chemotherapy regimen. Surgery is scheduled within 4-6 weeks of randomization (control arm) or after the last neoadjuvant cycle (intervention arm). Left pancreatectomy (open or minimally invasive) with standard lymphadenectomy and splenectomy is performed with complications reported using Dindo/Clavien classification and ISGPS criteria. Radical antegrade posterior pancreatosplenectomy may be performed when needed to ensure clear margins. Tumor response to neoadjuvant therapy will be evaluated by standardized histopathological grading.
Patients are followed with laboratory tests and CT imaging at the completion of adjuvant therapy and every six months thereafter until disease recurrence or up to five years after surgery. Quality of life is assessed at baseline, pre-surgery (in the neoadjuvant arm), 4 weeks post-op, and during follow-up using the EORTC QLQ-C30 and PAN26 instruments. Patients are followed for recurrence and survival every 6 months for up to 5 years. Safety is monitored per CTCAE v5.0, with SAEs and SUSARs reported per regulatory guidelines. An independent DSMB will review safety data. Blood and tumor samples will be stored for future translational research.
The primary endpoint is overall survival. A total of 381 patients will be enrolled over 36 months. The trial is powered to detect a hazard ratio of 0.70 with 80% power and a 5% significance level, requiring 247 events (deaths). Analysis will follow the intention-to-treat principle using Kaplan-Meier, log-rank test, and Cox regression. Pre-specified subgroup analyses will assess factors such as age, performance status, CA19-9, and tumor characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative chemotherapy | Experimental | Drug: mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabinePatients who undergo surgical resection will receive adjuvant chemotherapy with 4 cycles (2 months) of FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and 5-fluorouracil (400 mg/m2 bolus then 2400 mg/m2 over 46 h)) OR 2 cycles (2 months) of Gemcitabine 1000 mg/m2 over 30 min at day 1, 8, 15 of each 28-day cycle and capecitabine 830 mg/m2 ×2 daily for 3 weeks and one week rest of each 28-day cycle. Regimen changes due to toxicity are allowed. After 2 and 4 months of NAT, response imaging (multiphased body CT) is assessed at a local pancreatic MDT. If stable disease or regression is observed, patients will undergo surgery after chemotherapy break of 3-6 weeks. Adjuvant chemotherapy (2-4 months) must be started within 4-12 weeks after resection. Dose adjustments follow local practice; adjuvant therapy depends on patient condition (mFOLFIRINOX, Gem+capecitabine, or gemcitabine alone). |
| Control arm | No intervention | –After randomization, arm B patients are scheduled for upfront surgery. Adjuvant chemotherapy of 6 months must be started within 4-12 weeks after resection. Dose reduction or dose delays are acted upon according to local clinical practice at each centre. The adjuvant therapy is decided and if necessary modified according to patient's condition (mFOLFIRINOX, Gem+cabecitabine, single Gem). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Resectable left pancreatic cancer according to NCCN criteria
- Written and informed consent
- Age > 18y
- ECOG 0-2
- Fit for surgery
Key exclusion criteria (4 listed)
- ECOG > 2
- Histology other than ductal adenocarcinoma
- Unable to give written consent
- < 18y
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 |
|---|---|---|
| mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabineAlso: oxaliplatin, irinotecan, leucovorin, 5-fluorouracilThe benefits of neoadjuvant chemotherapy before surgery in a prospective multicenter randomized setting for resectable left-sided pancreatic cancer patients. | Drug | Perioperative chemotherapy |
Primary outcome
Overall Survival
Time frame: From randomization until death or study completion, up to approximately 5 years.
Overall survival of participants, defined as the time from randomization until death from any cause, analyzed in the intention-to-treat (ITT) population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
Hanna Seppänen, Adj. Prof., Pancreatic surgeon principal investigator
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine in people with Pancreatic Cancer Resectable, run by Helsinki University Central Hospital at 2 sites in Finland.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Seppänen, Adj. Prof., Pancreatic surgeon (+358-50-4270042, hanna.seppanen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From randomization until death or study completion, up to approximately 5 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 4 Sep 2025.