Acinar Cell Adenocarcinoma of the PancreasPhase 1NCT01739439
Chemoradiation and Radiosurgery Boost in Treating Patients With Locally Advance Pancreatic Cancer That May or May Not be Removed by Surgery
A Phase 1 study testing gemcitabine hydrochloride, hyperfractionated radiation therapy and intensity-modulated radiation therapy in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of radiosurgery boost following chemoradiation in treating patients with locally advanced pancreatic cancer that may or may not be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer
- What is being tested?
- gemcitabine hydrochloride, hyperfractionated radiation therapy and intensity-modulated radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 1 Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
- For the initial dose escalation study, patients must have locally advanced / unresectable pancreatic cancer; these are defined as follows:
- No distant metastases
- Hepatic artery encasement
- Superior mesenteric artery (SMA) encasement > 180 degrees
- Any celiac axis abutment
Show all 26Show fewer
- Unreconstructable superior mesenteric vein (SMV)/portal occlusion
- Aortic invasion or encasement
- Metastases to lymph nodes beyond the field of resection
- For the expansion phase, patients must have borderline resectable or locally advanced / unresectable pancreatic cancer; these are defined as follows:
- No distant metastases
- At least 45 degree abutment of the hepatic artery or SMA
- Any celiac axis abutment
- Near complete occlusion of the SMV or portal vein
- Unreconstructable or reconstructible SMV/portal occlusion
- Aortic invasion or encasement
- Metastases to lymph nodes beyond the field of resection
- Patients must have evaluable disease
- Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
- Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 1
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelets (PLT) >= 100,000/ul
- Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
- Bilirubin less then 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
- Serum creatinine < 1.5 x ULN
Who cannot join
- Patients who have had any prior therapy for pancreatic cancer
- Concurrent chemotherapy or biologic therapy
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- Scleroderma or active connective tissue disease
- Active inflammatory bowel disease
- Serious, active infections requiring treatment with IV antibiotics
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer
This phase I trial studies the side effects and best dose of radiosurgery boost following chemoradiation in treating patients with locally advanced pancreatic cancer that may or may not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to save the part of the body where the cancer started
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of a radiosurgery boost added to hypofractionated chemoradiation in patients with borderline resectable or unresectable pancreatic cancer.
SECONDARY OBJECTIVES:
- To determine the effect of a radiosurgery boost added to hypofractionated chemoradiation on surgical morbidity (specifically, healing of the surgical anastomoses and abdominal wounds and late hemorrhage from blood vessels in the field) in patients with advanced borderline resectable (BLR) or unresectable pancreatic cancer.
II. To evaluate the utility of diffusion-weighted magnetic resonance imaging (MRI) as an assessment of treatment response after chemoradiation followed by radiosurgery.
III. To determine the feasibility of collecting tissue for immunohistochemistry (IHC) analysis via endoscopic ultrasound or computed tomography (CT)-guided fine needle aspiration.
IV. To utilize pathologic response rates in dose escalated regions, hypofractionated regions, and the dose gradient region in between to better characterize the radiobiologic response of pancreatic cancer to radiation dose escalation.
OUTLINE: This is a dose-escalation study of radiosurgery.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once weekly and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) 5 days a week in weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
- Conditions
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, hyperfractionated radiation therapy, intensity-modulated radiation therapy, radiosurgery, diffusion-weighted magnetic resonance imaging
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
hyperfractionated radiation therapyRadiation
Undergo hyperfractionated IMRT
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo hyperfractionated IMRT
radiosurgeryRadiation
Also called radiation surgery
Undergo radiosurgery boost
diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemoradiation and radiosurgery) | Experimental | Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly and undergo hyperfractionated IMRT 5 days a week in weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: gemcitabine hydrochloride; Radiation: hyperfractionated radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: radiosurgery; Procedure: diffusion-weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD defined as the dose level in which 1 out of 6 patients observes dose-limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startMay 2013
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinar Cell Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739439
- Sponsor's protocol ID
- 12-046
- Other IDs
- NCI-2012-02729
- Status last verified
- Jul 2019
- First submitted
- 29 Nov 2012
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RT-054: A Phase I Study of Neoadjuvant Hypofractionated Chemoradiation Plus Radiosurgical Boost for Patients With Borderline Resectable and Locally Advanced Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01739439
- Acronym / sponsor ID
- 12-046
- Conditions
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2013 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 3 Dec 2012 (estimated)
- 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 phase I trial studies the side effects and best dose of radiosurgery boost following chemoradiation in treating patients with locally advanced pancreatic cancer that may or may not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to save the part of the body where the cancer started
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of a radiosurgery boost added to hypofractionated chemoradiation in patients with borderline resectable or unresectable pancreatic cancer.
SECONDARY OBJECTIVES:
- To determine the effect of a radiosurgery boost added to hypofractionated chemoradiation on surgical morbidity (specifically, healing of the surgical anastomoses and abdominal wounds and late hemorrhage from blood vessels in the field) in patients with advanced borderline resectable (BLR) or unresectable pancreatic cancer.
II. To evaluate the utility of diffusion-weighted magnetic resonance imaging (MRI) as an assessment of treatment response after chemoradiation followed by radiosurgery.
III. To determine the feasibility of collecting tissue for immunohistochemistry (IHC) analysis via endoscopic ultrasound or computed tomography (CT)-guided fine needle aspiration.
IV. To utilize pathologic response rates in dose escalated regions, hypofractionated regions, and the dose gradient region in between to better characterize the radiobiologic response of pancreatic cancer to radiation dose escalation.
OUTLINE: This is a dose-escalation study of radiosurgery.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once weekly and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) 5 days a week in weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemoradiation and radiosurgery) | Experimental | Drug: gemcitabine hydrochloride, Radiation: hyperfractionated radiation therapy, Radiation: intensity-modulated radiation therapy, Radiation: radiosurgery, Procedure: diffusion-weighted magnetic resonance imagingPatients receive gemcitabine hydrochloride IV over 30 minutes once weekly and undergo hyperfractionated IMRT 5 days a week in weeks 1-3. Patients then undergo a single fraction of radiosurgery boost in week 5 and then receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 6-8. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
- For the initial dose escalation study, patients must have locally advanced / unresectable pancreatic cancer; these are defined as follows:
- For the expansion phase, patients must have borderline resectable or locally advanced / unresectable pancreatic cancer; these are defined as follows:
- Patients must have evaluable disease
- Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
Key exclusion criteria (7 listed)
- Patients who have had any prior therapy for pancreatic cancer
- Concurrent chemotherapy or biologic therapy
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- Scleroderma or active connective tissue disease
- Active inflammatory bowel disease
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 |
|---|---|---|
| gemcitabine hydrochlorideAlso: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, GemzarGiven IV | Drug | Treatment (chemoradiation and radiosurgery) |
| hyperfractionated radiation therapyUndergo hyperfractionated IMRT | Radiation | Treatment (chemoradiation and radiosurgery) |
| intensity-modulated radiation therapyAlso: IMRTUndergo hyperfractionated IMRT | Radiation | Treatment (chemoradiation and radiosurgery) |
| radiosurgeryAlso: radiation surgeryUndergo radiosurgery boost | Radiation | Treatment (chemoradiation and radiosurgery) |
| diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRICorrelative studies | Procedure or surgery | Treatment (chemoradiation and radiosurgery) |
Primary outcome
MTD defined as the dose level in which 1 out of 6 patients observes dose-limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Week 5
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
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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.
Joshua Meyer principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemcitabine hydrochloride, hyperfractionated radiation therapy and intensity-modulated radiation therapy in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by Fox Chase Cancer Center at 1 site in United States.
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 26 inclusion and 7 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 29 Jul 2019. 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 United States. 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 was stopped early (reason given: Slow accrual). 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?
MTD defined as the dose level in which 1 out of 6 patients observes dose-limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (time frame: Week 5). 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 29 Jul 2019.