Cancer of PancreasPhase 2PIOPPONCT03822936
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
A Phase 2 study testing Preoperative chemotherapy and Preoperative radiotherapy in people with Cancer of Pancreas and Pancreas Adenocarcinoma, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial summary
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Pancreas, Pancreas Adenocarcinoma, Resectable Pancreatic Cancer
- What is being tested?
- Preoperative chemotherapy and Preoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2018to 10 Feb 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologic/cytologic diagnosis of exocrine pancreas tumour
- resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
- no metastasis from US, CT, PET, MRI or laparotomy
- Karnofsky index >= 70
- stomach and duodenum not infiltrated by tumour
- given informed consent to study procedures
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- Hb > 9 g/dL, N> 1500, PLT> 100000
- creatininemia < 1.5 mg/dL; bilirubinemia < 1.5 times upper normal values; albumin > 3 g/dL
- DPD normal activity
- contraception required and breast feeding not permitted
Who cannot join
- non resectable, locally advanced tumours
- insular cells tumour
- comorbidities excluding abdominal surgery and/or chemo- radiation therapy
- known metastasis
- DPD low activity
- inability to attend study procedures and follow ups
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- pregnancy
- previous diagnosis of other tumour with more disadvantageous prognosis then the study object
- metallic biliary stent
- metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
- clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
- medical and/or psychical condition preventing from radiation therapy
- past radiation therapy on abdomen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
Read the detailed description
Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy[RBE] is the prescribed dose to CTV. 4.8 Gy[RBE]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.
Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.
- Being tested
- Preoperative chemotherapy, Preoperative radiotherapy
- Keywords
- carbon ion radiation therapy, exocrine pancreas, pancreas tumour
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative chemotherapyDrug
Also called Folinic acid, Irinotecan, fluorouracil, oxaliplatin
Preoperative chemotherapy, carbon ion therapy, surgery
Preoperative radiotherapyRadiation
Also called Carbon ion therapy
Preoperative chemotherapy, carbon ion therapy, surgery
| Study group | Role | What they receive |
|---|---|---|
| Preoperatory chemoradiation therapy with carbon ions | Experimental | Chemoradiation followed by surgery Receives: Drug: Preoperative chemotherapy; Radiation: Preoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
The local progression free survival is measured
Measured: The local progression free survival will be assessed at 1-year
Secondary outcomes (4)
overall survival
the overall survival of enrolled patients is considered
Measured: The overall survival of enrolled patients will be assessed at 2-years
resectability rate R0 stratified (operable vs not operable)
how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients
Measured: time of surgery (4-6 weeks after radiotherapy)
Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
Measured: The incidence of acute and medium term toxicity will be assessed up to 90 and 180 post-operative days respectively. The incidence of late toxicity will be assessed through study completion, an average of 1 year.
intra and perioperatory complications
intra and perioperatory complications
Measured: The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start8 Feb 2018
- Primary completion8 Aug 2022
- Study completion10 Feb 2025
Why it stopped: The study was early closed due to low accrual in August 2022.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of PancreasStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Francesca Valvo, CNAO National Center of Oncological Hadrontherapy
- Investigators
- Francesca Valvo, MD, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822936
- Sponsor's protocol ID
- CNAO 35/2017 C
- Acronym
- PIOPPO
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barcellini A, Molinelli S, Vanoli A, Vitolo V, Fossati P, Vai A, Pagani A, Inzani F, Pecorilla M, Butturini G, Klersy C, Preda L, Facoetti A, Valvo F, Orlandi E. Preoperative chemo-CIRT in Re/BRe pancreatic cancer: Insights from a multicenter prospective phase II clinical study (NCT03822936). Tumori. 2024 Dec;110(6):470-474. doi: 10.1177/03008916241291341. Epub 2024 Oct 27.
PubMed 39462835Vitolo V, Cobianchi L, Brugnatelli S, Barcellini A, Peloso A, Facoetti A, Vanoli A, Delfanti S, Preda L, Molinelli S, Klersy C, Fossati P, Orecchia R, Valvo F. Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study. BMC Cancer. 2019 Sep 14;19(1):922. doi: 10.1186/s12885-019-6108-0.
PubMed 31521134
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
- ClinicalTrials.gov ID
- NCT03822936
- Acronym / sponsor ID
- PIOPPO / CNAO 35/2017 C
- Keywords
- carbon ion radiation therapy, exocrine pancreas, pancreas tumour
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was early closed due to low accrual in August 2022.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 30 Jan 2019 (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.
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
Detailed description
Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy[RBE] is the prescribed dose to CTV. 4.8 Gy[RBE]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.
Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Preoperatory chemoradiation therapy with carbon ions | Experimental | Drug: Preoperative chemotherapy, Radiation: Preoperative radiotherapyChemoradiation followed by surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologic/cytologic diagnosis of exocrine pancreas tumour
- resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
- no metastasis from US, CT, PET, MRI or laparotomy
- Karnofsky index >= 70
- stomach and duodenum not infiltrated by tumour
Key exclusion criteria (13 listed)
- non resectable, locally advanced tumours
- insular cells tumour
- comorbidities excluding abdominal surgery and/or chemo- radiation therapy
- known metastasis
- DPD low activity
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 |
|---|---|---|
| Preoperative chemotherapyAlso: Folinic acid, Irinotecan, fluorouracil, oxaliplatinPreoperative chemotherapy, carbon ion therapy, surgery | Drug | Preoperatory chemoradiation therapy with carbon ions |
| Preoperative radiotherapyAlso: Carbon ion therapyPreoperative chemotherapy, carbon ion therapy, surgery | Radiation | Preoperatory chemoradiation therapy with carbon ions |
Primary outcome
Progression free survival
Time frame: The local progression free survival will be assessed at 1-year
The local progression free survival is measured
4 secondary outcomes
overall survival
Time frame: The overall survival of enrolled patients will be assessed at 2-years
resectability rate R0 stratified (operable vs not operable)
Time frame: time of surgery (4-6 weeks after radiotherapy)
Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
Time frame: The incidence of acute and medium term toxicity will be assessed up to 90 and 180 post-operative days respectively. The incidence of late toxicity will be assessed through study completion, an average of 1 year.
intra and perioperatory complications
Time frame: The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days
Results and safety
The study was stopped early (reason given: The study was early closed due to low accrual in August 2022.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 39462835Barcellini A, Molinelli S, Vanoli A, Vitolo V, Fossati P, Vai A, Pagani A, Inzani F, Pecorilla M, Butturini G, Klersy C, Preda L, Facoetti A, Valvo F, Orlandi E. Preoperative chemo-CIRT in Re/BRe pancreatic cancer: Insights from a multicenter prospective phase II clinical study (NCT03822936). Tumori. 2024 Dec;110(6):470-474. doi: 10.1177/03008916241291341. Epub 2024 Oct 27.
- Derived from this study: PubMed 31521134Vitolo V, Cobianchi L, Brugnatelli S, Barcellini A, Peloso A, Facoetti A, Vanoli A, Delfanti S, Preda L, Molinelli S, Klersy C, Fossati P, Orecchia R, Valvo F. Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study. BMC Cancer. 2019 Sep 14;19(1):922. doi: 10.1186/s12885-019-6108-0.
- Individual participant dataSharing planned: No
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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.
Francesca Valvo, MD principal investigator
CNAO National Center of Oncological Hadrontherapy
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 Preoperative chemotherapy and Preoperative radiotherapy in people with Cancer of Pancreas and Pancreas Adenocarcinoma, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 13 Feb 2025. 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 Italy. 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?
The study was stopped early (reason given: The study was early closed due to low accrual in August 2022.). Results are not available in the source record.
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: The local progression free survival will be assessed at 1-year). 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 NCT03822936, which also lists 2 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 13 Feb 2025.