Pancreas Neoplasm Malignant ResectablePhase 2NCT02243358
Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
A Phase 2 study testing Folfox6, Gemcitabine and Radiation Therapy in people with Pancreas Neoplasm Malignant Resectable, run by Henry Ford Health System at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreas Neoplasm Malignant Resectable
- What is being tested?
- Folfox6, Gemcitabine and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 14 Jan 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma of the pancreatic head or body
- Patients must have radiographically-confirmed surgically resectable or borderline resectable disease at study entry staged at T1-3, NO-1 and MO
- Age >/= 18years
- Life expectancy of greater than 6 months in the opinion of the investigator, excluding theh pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status </= 1
- Required laboratory data (see protocol)
- Disease assessment by CT scan within 4 weeks of study entry
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients may not be receiving any other investigational agent
- Patients with metastatic disease are excluded from this clinical trial
- History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and gemcitabine
- No prior chemotherapy or radiation therapy for pancreatic cancer (previous chemotherapy or radiation therapy for other malignancies is permitted)
- Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study.
- Uncontrolled serious intercurrent illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements
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- Pregnant or breastfeeding women are excluded from this study.
- Known HIV-positive patients are ineligible
- Patients with unresectable disease are excluded form the protocol (see Appendix B for National Comprehensive cancer Network [NCCN] criteria for determining resectability status). Surgical resectability must be confirmed by a surgeon experienced in pancreatic surgery.
- Patients with pancreatic tail lesions will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.
Read the detailed description
The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine chemotherapy at standard dosing.
Secondary objectives are to determine overall survival and progression-free survival as a function of time from study enrollment and to evaluate tolerability and toxicity of protocol treatment.
Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days) after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical procedure performed will be that required for a complete resection, and this will be based on the discretion of the operating surgeon. Patients will be followed for 1 year after completion of neoadjuvant therapy or until removal or termination from study, or until death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from completion of protocol therapy.
- Conditions
- Pancreas Neoplasm Malignant Resectable
- Being tested
- Folfox6, Gemcitabine, Radiation Therapy, Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
- Keywords
- Pancreatic, cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folfox6Drug
Also called 5 fluoropyrimidine
GemcitabineDrug
Also called Gemzar
Radiation TherapyRadiation
Pancreaticoduodenectomy with retroperitoneal lymphadenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemo-Radiotherapy and Resection | Experimental | 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) Receives: Drug: Folfox6; Drug: Gemcitabine; Radiation: Radiation Therapy; Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of R0 Resection
Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completion28 Jun 2017
- Study completion14 Jan 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas Neoplasm Malignant ResectableStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gazala Khan, MD, Henry Ford Health System
- Investigators
- Gazala Khan, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243358
- Sponsor's protocol ID
- HFHS 13-03
- Status last verified
- Oct 2023
- First submitted
- 4 Sep 2014
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Through publication in peer reviewed journal
Publications
Thanikachalam K, Damarla V, Seixas T, Dobrosotskaya I, Wollner I, Kwon D, Winters K, Raoufi M, Li J, Siddiqui F, Khan G. Neoadjuvant Phase II Trial of Chemoradiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer. Am J Clin Oncol. 2020 Jun;43(6):435-441. doi: 10.1097/COC.0000000000000688.
PubMed 32251119
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02243358
- Acronym / sponsor ID
- HFHS 13-03
- Conditions
- Pancreas Neoplasm Malignant Resectable
- Keywords
- Pancreatic, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.
Detailed description
The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine chemotherapy at standard dosing.
Secondary objectives are to determine overall survival and progression-free survival as a function of time from study enrollment and to evaluate tolerability and toxicity of protocol treatment.
Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days) after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical procedure performed will be that required for a complete resection, and this will be based on the discretion of the operating surgeon. Patients will be followed for 1 year after completion of neoadjuvant therapy or until removal or termination from study, or until death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from completion of protocol therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemo-Radiotherapy and Resection | Experimental | Drug: Folfox6, Drug: Gemcitabine, Radiation: Radiation Therapy, Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma of the pancreatic head or body
- Patients must have radiographically-confirmed surgically resectable or borderline resectable disease at study entry staged at T1-3, NO-1 and MO
- Age >/= 18years
- Life expectancy of greater than 6 months in the opinion of the investigator, excluding theh pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status </= 1
Key exclusion criteria (10 listed)
- Patients may not be receiving any other investigational agent
- Patients with metastatic disease are excluded from this clinical trial
- History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and gemcitabine
- No prior chemotherapy or radiation therapy for pancreatic cancer (previous chemotherapy or radiation therapy for other malignancies is permitted)
- Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study.
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 |
|---|---|---|
| Folfox6Also: 5 fluoropyrimidine | Drug | Neoadjuvant Chemo-Radiotherapy and Resection |
| GemcitabineAlso: Gemzar | Drug | Neoadjuvant Chemo-Radiotherapy and Resection |
| Radiation Therapy | Radiation | Neoadjuvant Chemo-Radiotherapy and Resection |
| Pancreaticoduodenectomy with retroperitoneal lymphadenectomy | Procedure or surgery | Neoadjuvant Chemo-Radiotherapy and Resection |
Primary outcome
Frequency of R0 Resection
Time frame: 6 weeks
Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32251119Thanikachalam K, Damarla V, Seixas T, Dobrosotskaya I, Wollner I, Kwon D, Winters K, Raoufi M, Li J, Siddiqui F, Khan G. Neoadjuvant Phase II Trial of Chemoradiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer. Am J Clin Oncol. 2020 Jun;43(6):435-441. doi: 10.1097/COC.0000000000000688.
- Individual participant dataSharing planned: Yes. Through publication in peer reviewed journal
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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.
Gazala Khan, MD principal investigator
Henry Ford Health System
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 Folfox6, Gemcitabine and Radiation Therapy in people with Pancreas Neoplasm Malignant Resectable, run by Henry Ford Health System 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 8 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: finished, as of the sponsor's last update on 27 Oct 2023. 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 27 Oct 2023). 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?
Frequency of R0 Resection (time frame: 6 weeks). 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 NCT02243358, which also lists 1 linked publication.
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 27 Oct 2023.