Pancreatic CancerPhase 3NCT04592861
Carbon Ion RT for Locally Advanced Pancreatic Cancer
A Phase 3 study testing carbon ion RT and Chemotherapy drug in people with Pancreatic Cancer, run by Albert Einstein College of Medicine at 1 site in China.
Trial summary
This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- carbon ion RT and Chemotherapy drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 24 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
- Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
- Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
- major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
- No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
- ECOG Performance Status 0-1 within 30 days prior to registration
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- Age ≥ 18
- CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
- Additional laboratory studies within 14 days prior to registration demonstrating:
- Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)
- Bilirubin < 1.5 x ULN
- ALT and AST ≤ 2.5 x ULN
- aPTT, PT ≤ 1.5 x ULN
- Patients must provide study specific informed consent prior to study entry.
- Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
Who cannot join
- More than one primary lesion
- Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
- Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years is permitted.
- Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation.
- Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment.
- FOLFIRINOX
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- Gemcitabine/nab-paclitaxel
- Gemcitabine
- S-1
- Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Proton and Heavy Ion Center (SPHIC)
Shanghai, Shanghai Municipality, 201315
About this study
Official title: A Prospective, Randomized, Phase 3 Trial of Carbon Ion Radiation Therapy Versus Standard Care for Locally Advanced Pancreatic Cancer
This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.
- Conditions
- Pancreatic Cancer
- Being tested
- carbon ion RT, Chemotherapy drug
- Keywords
- pancreatic cancer, carbon ion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion RTRadiation
daily carbon ion radiotherapy
Chemotherapy drugDrug
Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Carbon ion radiotherapy | Experimental | Carbon ion radiotherapy will be administered 5 days each week (Monday-Friday). The prescription dose will be 60 GyE in 20 fractions, to be delivered over four weeks. Receives: Radiation: carbon ion RT; Drug: Chemotherapy drug |
| Routine standard of care | Active comparator | Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs. Receives: Drug: Chemotherapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival duration
The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.
Measured: The length of time from randomization until death from any cause for up to 24 months
Secondary outcomes (4)
Progression-free survival duration
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Measured: he length of time from study registration until disease progression at any site or death from any cause, up to 24 months
Local disease progression scored using RECIST 1.1 criteria
A set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment
Measured: Up to 24 months
Adverse events as defined by CTCAE v5.0
A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
Measured: Up to 24 months
Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire
Questionnaire developed to measure the quality of life of cancer patients. Composite scores range from 0 to 100, with higher scores being more favorable.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Why it stopped: Study administratively closed out by the Einstein IRB. NO US enrolling sites.
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.
- 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
- Model description
- This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Proton and Heavy Ion Center
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592861
- Sponsor's protocol ID
- 2020-11511
- Status last verified
- Jan 2024
- First submitted
- 11 Sep 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Phase 3 Trial of Carbon Ion Radiation Therapy Versus Standard Care for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04592861
- Acronym / sponsor ID
- 2020-11511
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, carbon ion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study administratively closed out by the Einstein IRB. NO US enrolling sites.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Proton and Heavy Ion Center
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 19 Oct 2020 (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 an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer.
| Arm | Type | Receives |
|---|---|---|
| Carbon ion radiotherapy | Experimental | Radiation: carbon ion RT, Drug: Chemotherapy drugCarbon ion radiotherapy will be administered 5 days each week (Monday-Friday). The prescription dose will be 60 GyE in 20 fractions, to be delivered over four weeks. |
| Routine standard of care | Active comparator | Drug: Chemotherapy drugSubjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
- Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
- Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
- major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
- No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
Key exclusion criteria (10 listed)
- More than one primary lesion
- Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
- Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years is permitted.
- Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation.
- Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment.
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 ion RTdaily carbon ion radiotherapy | Radiation | Carbon ion radiotherapy |
| Chemotherapy drugSubjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. | Drug | Carbon ion radiotherapy, Routine standard of care |
Primary outcome
Overall survival duration
Time frame: The length of time from randomization until death from any cause for up to 24 months
The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.
4 secondary outcomes
Progression-free survival duration
Time frame: he length of time from study registration until disease progression at any site or death from any cause, up to 24 months
Local disease progression scored using RECIST 1.1 criteria
Time frame: Up to 24 months
Adverse events as defined by CTCAE v5.0
Time frame: Up to 24 months
Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire
Time frame: up to 24 months
Results and safety
The study was stopped early (reason given: Study administratively closed out by the Einstein IRB. NO US enrolling sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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.
Nitin Ohri, MD principal investigator
Associate Professor
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 carbon ion RT and Chemotherapy drug in people with Pancreatic Cancer, run by Albert Einstein College of Medicine 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 18 inclusion and 10 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 5 Jan 2024. 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?
The study was stopped early (reason given: Study administratively closed out by the Einstein IRB. NO US enrolling sites.). 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?
Overall survival duration (time frame: The length of time from randomization until death from any cause for up to 24 months). 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 5 Jan 2024.