Adenocarcinoma of Head of PancreasPhase 2NCT01677988
Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma
A Phase 2 study testing Neo-adjuvant Chemotherapy, Chemoradiation and Surgical Resection in people with Adenocarcinoma of Head of Pancreas, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenocarcinoma of Head of Pancreas
- What is being tested?
- Neo-adjuvant Chemotherapy, Chemoradiation and Surgical Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has histologically or cytologically confirmed borderline resectable adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine neoplasms are excluded.
- Borderline resectable disease as outlined in the protocol
- ≥ 18 years of age.
- Male or non-pregnant and non-lactating female. If a female patient is of childbearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
- Patient must not have received prior chemotherapy or radiation for pancreatic cancer and no exposure to systemic chemotherapy.
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- Patient have acceptable blood counts, chemistries \& coagulation at baseline as outlined in the protocol
- Patient has an ECOG performance status PS 0-1.
- Patient has been informed about the nature of the study and has agreed to participate in the study and signed the Informed Consent Form prior to participation in any study-related activities.
- Endoscopic ultrasound (EUS) with FNA for cytology.
- Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics.
Who cannot join
- Patient has localized resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are ineligible.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV.
- Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.
- Patient has a history of allergy or hypersensitivity to the study drugs.
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- Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy.
- Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine).
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
- Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before randomization.
- Patients must not have a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
- Patient is unwilling or unable to comply with study procedures.
- Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
- Patients aged > 70
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma
This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.
- Conditions
- Adenocarcinoma of Head of Pancreas
- Being tested
- Neo-adjuvant Chemotherapy, Chemoradiation, Surgical Resection
- Keywords
- NEOADJUVANT FOLFIRINOX CHEMOTHERAPY, LOCALIZED PANCREATIC HEAD ADENOCARCINOMA, RADIATION THERAPY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-adjuvant ChemotherapyDrug
Also called FOLFIRINOX chemotherapy
- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.
- Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)
- Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.
- Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.
ChemoradiationRadiation
- Chemoradiation may be administered at selected approved CTN sites.
- Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board.
- Unresectable → Off study. Subsequent treatment per patient's primary MD.
- Resectable → Continue to Registration #3 for Surgical Resection
Surgical ResectionProcedure or surgery
- Meets criteria for resectable* →pancreaticoduodenectomy (POD)
- At time of resection, snap frozen tumor specimen sent for correlative biomarker studies
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy, Chemoradiation, Surgery | Experimental | Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection Receives: Drug: Neo-adjuvant Chemotherapy; Radiation: Chemoradiation; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the R0/R1 Resection Rate
Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.
Measured: at time of surgery
Secondary outcomes (4)
Radiographic Tumor Response
The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.
Measured: From enrollment to Surgery
Histopathologic Tumor Response
Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.
Measured: at the time of surgery
Time to Recurrence:
Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.
Measured: 2 years
Overall Survival:
Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2015
Why it stopped: Study was terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of Head of PancreasStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul O'Brien, Medical University of South Carolina
- Investigators
- Paul E. O'Brien, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677988
- Sponsor's protocol ID
- 101822
- Status last verified
- Jul 2015
- First submitted
- 29 Aug 2012
- Last updated
- 15 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01677988
- Acronym / sponsor ID
- 101822
- Conditions
- Adenocarcinoma of Head of Pancreas
- Keywords
- NEOADJUVANT FOLFIRINOX CHEMOTHERAPY, LOCALIZED PANCREATIC HEAD ADENOCARCINOMA, RADIATION THERAPY
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low accrual.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Posted 15 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy, Chemoradiation, Surgery | Experimental | Drug: Neo-adjuvant Chemotherapy, Radiation: Chemoradiation, Procedure: Surgical ResectionNeoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient has histologically or cytologically confirmed borderline resectable adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine neoplasms are excluded.
- Borderline resectable disease as outlined in the protocol
- ≥ 18 years of age.
- Male or non-pregnant and non-lactating female. If a female patient is of childbearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
Key exclusion criteria (14 listed)
- Patient has localized resectable, locally advanced unresectable or advanced metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are ineligible.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV.
- Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.
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 |
|---|---|---|
| Neo-adjuvant ChemotherapyAlso: FOLFIRINOX chemotherapy1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support. 2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team) 1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD. 2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation. | Drug | Chemotherapy, Chemoradiation, Surgery |
| Chemoradiation1. Chemoradiation may be administered at selected approved CTN sites. 2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board. 1. Unresectable → Off study. Subsequent treatment per patient's primary MD. 2. Resectable → Continue to Registration #3 for Surgical Resection | Radiation | Chemotherapy, Chemoradiation, Surgery |
| Surgical Resection1. Meets criteria for resectable* →pancreaticoduodenectomy (POD) 2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies | Procedure or surgery | Chemotherapy, Chemoradiation, Surgery |
Primary outcome
Estimate the R0/R1 Resection Rate
Time frame: at time of surgery
Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.
4 secondary outcomes
Radiographic Tumor Response
Time frame: From enrollment to Surgery
Histopathologic Tumor Response
Time frame: at the time of surgery
Time to Recurrence:
Time frame: 2 years
Overall Survival:
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul E. O'Brien, MD principal investigator
Medical University of South Carolina
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 Neo-adjuvant Chemotherapy, Chemoradiation and Surgical Resection in people with Adenocarcinoma of Head of Pancreas, run by Medical University of South Carolina 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 11 inclusion and 14 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 15 Jan 2016. 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 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?
Yes. Results are posted in the registry (first posted 15 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Estimate the R0/R1 Resection Rate (time frame: at time of surgery). 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 15 Jan 2016.