Pancreatic CancerPhase 1NCT03403049
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer
A Phase 1 study testing Carbon Ion, Gemcitabine + Cisplatin and Gemcitabine + Capecitabine in people with Pancreatic Cancer and Cancer, run by Montefiore Medical Center at 2 sites in 2 countries.
Trial summary
This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatic Cancer, Cancer
- What is being tested?
- Carbon Ion, Gemcitabine + Cisplatin and Gemcitabine + Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2016to 9 Jul 2019
- Phase
- Phase 1
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form;
- Age ≥ 18;
- Capable of following the protocol
- Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
- Unresectable adenocarcinoma of the pancreas by radiographic criteria according to the criteria of the NCCN Guidelines and based on post-chemotherapy imaging or due to medical contraindications to radical resection;
- No evidence of distant metastases based on imaging evaluation;
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- Maximum tumor and positive lymph node diameter ≤ 6 cm;
- ECOG Performance Status 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥9 g/dL (use of transfusion to achieve said levels or greater is acceptable);
- Adequate liver function: total bilirubin <1.5 x ULN, and AST and ALT <2.5 x ULN;
- Adequate kidney function: serum creatinine ≤1.25 x ULN or calculated creatinine clearance rate ≥50mL/min and urine protein <2+.If the patient's baseline urine protein is at ≥2+, urine samples must be taken for 24 hours to verify that urine protein is ≤1g;
- Laboratory studies within 14 days prior to registration demonstrating that the internationalization standard ratio (INR) ≤1.5 and prothrombin time (PPT) ≤1.5 x ULN.
- Prior receipt of 2-4 cycles of Gemcitabine-based systemic chemotherapy.
Who cannot join
- Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
- ECOG Performance Status >=2;
- Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
- Persistent grade ≥ 2 toxicity due to previous cancer treatment;
- Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
- Those wearing a cardiac pacemaker or another type of metal prosthetic implant whose normal functions may suffer interference from high energy radiation or that could affect the radiation target area;
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- Where it is not possible to achieve the predetermined safety dose limit with the dose equivalent limit of the organ at risk such as the liver or digestive tract, etc.;
- If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient;
- Patients suffering from another illness or other factors that could affect the proton or carbon ion therapy;
- Pregnant (verified by serum or urine β-HCG test) or breastfeeding females;
- Drug-abuse or alcohol dependency;
- HIV positive, including those that have received antiretroviral therapy; replicative stage of chronic Hepatitis B virus; active stage of Hepatitis C; and active stage of syphilis;
- HBV positive patients suffering from replicative stage of hepatitis virus, requiring antiretroviral therapy but cannot due to a concomitant disease;
- Patients with a history of mental illness that may prevent their completion of treatment;
- Patients with serious complications that could affect the course of treatment, including:
- Unstable angina, congestive heart failure, or myocardial infarction requiring hospital admittance over the last 6 months;
- Acute or systemic bacterial infection;
- Chronic exacerbated obstructive pulmonary disease or other respiratory system disease requiring inpatient treatment;
- Impaired liver function or impaired kidney function;
- Patients suffering from immunosuppression;
- Patients with contraindications to receiving radiotherapy, such as a serious connective tissue disease (eg: scleroderma)
- Patients that are unable to understand the objective of the treatment/cannot sign the informed consent form;
- Patients that lack civil capacity to act or whose civil capacity to act is limited.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
China1 site
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality
About this study
Official title: A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer
This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.
- Conditions
- Pancreatic Cancer, Cancer
- Being tested
- Carbon Ion, Gemcitabine + Cisplatin, Gemcitabine + Capecitabine, Gemcitabine + Erlotinib, Gemcitabine
- Keywords
- pancreatic cancer, pancreas, cancer, locally advanced, unresectable, radiation, radiation therapy, radiotherapy, carbon, carbon ion, ion
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon IonRadiation
Study subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well.
Gemcitabine + CisplatinDrug
Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.
Gemcitabine + CapecitabineDrug
Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.
Gemcitabine + ErlotinibDrug
Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.
GemcitabineDrug
Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.
PhotonRadiation
During this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE). Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B). Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Dose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons. Receives: Radiation: Carbon Ion; Drug: Gemcitabine + Cisplatin; Drug: Gemcitabine + Capecitabine; Drug: Gemcitabine + Erlotinib; Drug: Gemcitabine; Radiation: Photon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Any CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.
Measured: 90 days
Secondary outcomes (5)
Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0
Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0
Measured: through study completion, an average of 1 year
Radiographic changes following completion of study therapy (RECIST v. 1.1)
Radiographic changes following completion of study therapy (RECIST v. 1.1)
Measured: through study completion, an average of 1 year
Overall survival duration
The length of time from study inclusion until death from any cause
Measured: through study completion, an average of 1 year
Progression-free survival duration
The length of time from study inclusion until death from any cause or disease progression at any site
Measured: through study completion, an average of 1 year
The impact in terms of overall quality of life of radiation therapy as assessed by the QLQ-C30 questionnaire
Quality of life will be assessed at various time points using the European Organisation for Research and Treatment of Cancer 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many cancer related clinical trials.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Apr 2016
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Proton and Heavy Ion Center
- Responsible party
- Sponsor
- Investigators
- Chandan Guha, M.B.B.S., Ph.D., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403049
- Sponsor's protocol ID
- 2015-5026
- Other IDs
- 261201500022C-0-0-1
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2016
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03403049
- Acronym / sponsor ID
- 2015-5026
- Conditions
- Pancreatic Cancer, Cancer
- Keywords
- pancreatic cancer, pancreas, cancer, locally advanced, unresectable, radiation, radiation therapy, radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Shanghai Proton and Heavy Ion Center
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 18 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 is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: Carbon Ion, Drug: Gemcitabine + Cisplatin, Drug: Gemcitabine + Capecitabine, Drug: Gemcitabine + Erlotinib, Drug: Gemcitabine, Radiation: PhotonDose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed the informed consent form;
- Age ≥ 18;
- Capable of following the protocol
- Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
- Unresectable adenocarcinoma of the pancreas by radiographic criteria according to the criteria of the NCCN Guidelines and based on post-chemotherapy imaging or due to medical contraindications to radical resection;
Key exclusion criteria (23 listed)
- Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
- ECOG Performance Status >=2;
- Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
- Persistent grade ≥ 2 toxicity due to previous cancer treatment;
- Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
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 |
|---|---|---|
| Carbon IonStudy subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well. | Radiation | Arm 1 |
| Gemcitabine + CisplatinCombined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. | Drug | Arm 1 |
| Gemcitabine + CapecitabineCombined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. | Drug | Arm 1 |
| Gemcitabine + ErlotinibCombined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. | Drug | Arm 1 |
| GemcitabineCombined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen. All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy. | Drug | Arm 1 |
| PhotonDuring this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE). Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B). Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol. | Radiation | Arm 1 |
Primary outcome
Dose-limiting toxicity
Time frame: 90 days
Any CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.
5 secondary outcomes
Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0
Time frame: through study completion, an average of 1 year
Radiographic changes following completion of study therapy (RECIST v. 1.1)
Time frame: through study completion, an average of 1 year
Overall survival duration
Time frame: through study completion, an average of 1 year
Progression-free survival duration
Time frame: through study completion, an average of 1 year
The impact in terms of overall quality of life of radiation therapy as assessed by the QLQ-C30 questionnaire
Time frame: through study completion, an average of 1 year
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chandan Guha, M.B.B.S., Ph.D. principal investigator
Albert Einstein College of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carbon Ion, Gemcitabine + Cisplatin and Gemcitabine + Capecitabine in people with Pancreatic Cancer and Cancer, run by Montefiore Medical Center at 2 sites in 2 countries.
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 14 inclusion and 23 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 13 Apr 2026. 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 United States, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Dose-limiting toxicity (time frame: 90 days). 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 13 Apr 2026.