Stage IA Pancreatic CancerPhase 1NCT01918644

Neoadjuvant SBRT With Concomitant Capecitabine in Resectable Pancreatic Cancer

A Phase 1 study testing stereotactic body radiation therapy, capecitabine and therapeutic conventional surgery in people with Stage IA Pancreatic Cancer and Stage IB Pancreatic Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer
What is being tested?: stereotactic body radiation therapy, capecitabine and therapeutic conventional surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 8 Apr 2014to 26 Apr 2022
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed carcinoma of exocrine pancreatic head amenable to oncological surgical resection per findings on a pancreatic-specific computed tomography (CT) or MRI scan. Tumors of the body that allow a surgical approach similar to pancreatic head tumors are acceptable.
Must be deemed a surgical candidate by the surgical oncology service.
Eastern Cooperative Oncology Group (ECOG) performance score of =< 2
Signed informed consent document(s)
Patients with no evidence of regional or distant metastatic disease based on CT scan of the chest/ abdomen/pelvis.
Absolute neutrophil count (ANC) >= 1,500 cells/mm3

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Platelet count >= 100,000 cells/mm3
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal
Total bilirubin =< 3 times the upper limit of normal if patient had recent biliary stenting, total bilirubin =< 1.5 times the upper limit of normal if no biliary stenting was done
Serum creatinine within normal range with a creatinine clearance >= 30 ml/min
Neoadjuvant chemotherapy will be permitted prior to the initiation of SBRT radiation therapy on this clinical trial. There must be a minimum of 2 weeks between the completion of any neoadjuvant chemotherapy and the beginning of SBRT radiation therapy. Furthermore, restaging must be done prior to registration to ensure that patients remain resectable.

Who cannot join

Patients with primary ampullary, biliary or duodenal cancer would be excluded
Patients with tumors primarily of the body or tail of the pancreas requiring a distal pancreaticoduodenectomy would be excluded
(H/ o) Crohn's disease/ ulcerative colitis/ scleroderma
History of prior allergic reactions attributed to compounds of similar chemical or biologic composition as capecitabine
History of prior allergic reactions attributed to compounds of CT/ MRI contrast that cannot be managed with appropriate pre-medication prophylaxis and thereby preclude use of baseline/ follow-up or radiation planning imaging
Any prior external beam radiation will be evaluated to determine radiation field overlaps and appropriateness of protocol radiation, any invasive cancer in the last 5 years (except for a diagnosis of low-risk prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)

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Pregnant or nursing women; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the point of study entry and for the duration of all active treatments; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Treatment with a non-approved or investigational drug within 28 days of study treatment
History of having MRI non-compatible metal (injury- or treatment-related) in the body will be an exclusion criteria specific to the MRI sub-study
Considering the small size of the PET/MR scanner bore, subjects with known severe claustrophobia or with body habitus not compatible with the bore (>300lbs, BMI>40) may also have to be excluded.
Subjects unable to maintain blood glucose less than 200mg/dl may not be suitable for the PET/MRI substudy.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Phase Ia-Ib Dose-escalation Study Evaluating Safety and Efficacy of Neoadjuvant Stereotactic Body Radiotherapy (SBRT) With Concomitant Capecitabine Chemotherapy for Resectable Carcinoma of Exocrine Pancreas.

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with capecitabine before surgery in treating patients with pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy and capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the recommended-phase-II-dose (RPTD) of stereotactic body radiation therapy (SBRT) at an escalating dose schedule when combined with standard-dose capecitabine as neoadjuvant therapy for resectable carcinoma of exocrine pancreas.

SECONDARY OBJECTIVES:

To estimate the incidence of overall 30-day post-operative complications.

II. To estimate the radiological response rates.

III. To estimate the pathological response rates.

IV. To estimate the rates of resection with negative margins.

To estimate the recurrence free survival (RFS).

VI. To estimate the overall survival (OS).

TERTIARY OBJECTIVES (OPTIONAL):

To define tumor volume (TV), dynamic contrast enhancement (DCE) pattern and mean apparent diffusion coefficient (ADC) measurements in diffusion-weighted magnetic resonance (MR) imaging (DWI) in patients with resectable pancreatic cancer undergoing neoadjuvant SBRT and concomitant chemotherapy (ChT).

II. To correlate TV, DCE and ADC measurements at baseline magnetic resonance imaging (MRI) versus final pathological response.

III. To correlate TV, DCE and ADC changes from baseline in MRI done three weeks post-SBRT versus final pathological response.

IV. To predict surgical margin status using MRI done at baseline and at three weeks post-SBRT.

To correlate TV, DCE and ADC changes from baseline in MRI done post-3rd fraction at baseline versus final pathological response.

VI. To describe in the biopsy and/ or the surgical specimen, expression of following markers: secreted protein acidic and rich in cysteine (SPARC) expression; distribution of pancreatic stellate cells (PSC); distribution of cluster of differentiation (CD)4+/ CD8+ T cell, CD56+ natural killer (NK) cells; other molecular and inflammatory cellular markers may be explored.

VII. To describe changes induced by neoadjuvant therapy by comparison of expression of these markers between the biopsy and the surgical specimen.

VIII. To compare baseline and/ or post-treatment expression with treatment response, toxicity and clinical survival outcome.

OUTLINE: This is a dose-escalation study of SBRT.

Participants undergo SBRT every other day over 2 weeks for a total of 5 fractions and receive capecitabine orally (PO) every 12 hours 5 days a week for 2 weeks. Participants then undergo definitive surgery after a minimum of 2 weeks from the completion of SBRT.

After completion of study treatment, participants are followed up at 1 month and 3 months, every 3 months for 1 year, and then every 6 months for 2 years.

Conditions: Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer
Being tested: stereotactic body radiation therapy, capecitabine, therapeutic conventional surgery, magnetic resonance imaging, laboratory biomarker analysis
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stereotactic body radiation therapyRadiation
Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo SBRT
capecitabineDrug
Also called CAPE, Ro 09-1978/000, Xeloda
Given PO
therapeutic conventional surgeryProcedure or surgery
Undergo definitive surgery
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Optional correlative studies
laboratory biomarker analysisOther
Optional correlative studies

Study groups in NCT01918644
Study group	Role	What they receive
Treatment (SBRT, capecitabine, and surgery)	Experimental	Patients undergo SBRT every other day over 2 weeks for a total of 5 fractions and receive capecitabine PO every 12 hours 5 days a week for 2 weeks. Patients then undergo definitive surgery after a minimum of 2 weeks from the completion of SBRT. Receives: Radiation: stereotactic body radiation therapy; Drug: capecitabine; Procedure: therapeutic conventional surgery; Procedure: magnetic resonance imaging; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of dose-limiting toxicity defined as any grade 3-4 non-hematologic toxicity or grade 5 toxicity attributable to combination chemo-radiotherapy per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The number and percent of patients reporting adverse events (all, severe or worse, serious and related) will be quantified for each dose level.
Measured: Up to 90 days from the start of SBRT and capecitabine

Secondary outcomes (6)

Incidence of 30-day post-operative complications
Will be expressed as a percentage.
Measured: 30 days
Radiological response per Response Evaluation Criteria in Solid Tumors (RECIST) and volumetric measurements
Will be expressed as a percentage.
Measured: Up to 3 years
Pathological response, graded based on the College of American Pathologists (CAP) and Ishikawa, Evans, and Chun grading systems
Will be expressed as a percentage.
Measured: Up to 3 years
Incidence of margin-negative resection, defined as the absence of viable tumor cells at the inked surgical margin
Will be expressed as a percentage.
Measured: Up to 3 years
Loco-regional recurrence free survival, defined with follow-up radiological assessment
Kaplan-Meier estimates will be calculated. Log-rank test and Cox regression analysis will be used for univariate and multivariate analyses, respectively. Chi square and regression analysis will be performed to test association of categorical variables with treatment response.
Measured: From the point of start of SBRT to the point of recurrence or death, assessed up to 3 years
OS
Kaplan-Meier estimates will be calculated. Log-rank test and Cox regression analysis will be used for univariate and multivariate analyses, respectively. Chi square and regression analysis will be performed to test association of categorical variables with treatment response.
Measured: From the point of start of SBRT to the time of death or last follow-up if alive, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 201426 Apr 2022

First posted8 Aug 2013 (estimated)
Study start8 Apr 2014
Primary completion4 Dec 2019
Study completion26 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage IA Pancreatic CancerStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01918644
Sponsor's protocol ID: 2017-1499
Other IDs: NCI-2013-01347, 2013-0645, RO12210, A533300, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, Protocol Version 2/6/2018
Status last verified: May 2022
First submitted: 5 Aug 2013
Last updated: 1 Jun 2022
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stage IA Pancreatic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ia-Ib Dose-escalation Study Evaluating Safety and Efficacy of Neoadjuvant Stereotactic Body Radiotherapy (SBRT) With Concomitant Capecitabine Chemotherapy for Resectable Carcinoma of Exocrine Pancreas.
ClinicalTrials.gov ID: NCT01918644
Acronym / sponsor ID: 2017-1499
Conditions: Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 8 Apr 2014 (actual)
Primary completion: 4 Dec 2019 (actual)
Study completion: 26 Apr 2022 (actual)
First posted: 8 Aug 2013 (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.

Detailed description

PRIMARY OBJECTIVES:

To determine the recommended-phase-II-dose (RPTD) of stereotactic body radiation therapy (SBRT) at an escalating dose schedule when combined with standard-dose capecitabine as neoadjuvant therapy for resectable carcinoma of exocrine pancreas.

SECONDARY OBJECTIVES:

To estimate the incidence of overall 30-day post-operative complications.

II. To estimate the radiological response rates.

III. To estimate the pathological response rates.

IV. To estimate the rates of resection with negative margins.

To estimate the recurrence free survival (RFS).

VI. To estimate the overall survival (OS).

TERTIARY OBJECTIVES (OPTIONAL):

To define tumor volume (TV), dynamic contrast enhancement (DCE) pattern and mean apparent diffusion coefficient (ADC) measurements in diffusion-weighted magnetic resonance (MR) imaging (DWI) in patients with resectable pancreatic cancer undergoing neoadjuvant SBRT and concomitant chemotherapy (ChT).

II. To correlate TV, DCE and ADC measurements at baseline magnetic resonance imaging (MRI) versus final pathological response.

III. To correlate TV, DCE and ADC changes from baseline in MRI done three weeks post-SBRT versus final pathological response.

IV. To predict surgical margin status using MRI done at baseline and at three weeks post-SBRT.

To correlate TV, DCE and ADC changes from baseline in MRI done post-3rd fraction at baseline versus final pathological response.

VII. To describe changes induced by neoadjuvant therapy by comparison of expression of these markers between the biopsy and the surgical specimen.

VIII. To compare baseline and/ or post-treatment expression with treatment response, toxicity and clinical survival outcome.

OUTLINE: This is a dose-escalation study of SBRT.

After completion of study treatment, participants are followed up at 1 month and 3 months, every 3 months for 1 year, and then every 6 months for 2 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (SBRT, capecitabine, and surgery)	Experimental	Radiation: stereotactic body radiation therapy, Drug: capecitabine, Procedure: therapeutic conventional surgery, Procedure: magnetic resonance imaging, Other: laboratory biomarker analysisPatients undergo SBRT every other day over 2 weeks for a total of 5 fractions and receive capecitabine PO every 12 hours 5 days a week for 2 weeks. Patients then undergo definitive surgery after a minimum of 2 weeks from the completion of SBRT.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Histologically or cytologically confirmed carcinoma of exocrine pancreatic head amenable to oncological surgical resection per findings on a pancreatic-specific computed tomography (CT) or MRI scan. Tumors of the body that allow a surgical approach similar to pancreatic head tumors are acceptable.
Must be deemed a surgical candidate by the surgical oncology service.
Eastern Cooperative Oncology Group (ECOG) performance score of =< 2
Signed informed consent document(s)
Patients with no evidence of regional or distant metastatic disease based on CT scan of the chest/ abdomen/pelvis.

Key exclusion criteria (11 listed)

Patients with primary ampullary, biliary or duodenal cancer would be excluded
Patients with tumors primarily of the body or tail of the pancreas requiring a distal pancreaticoduodenectomy would be excluded
(H/ o) Crohn's disease/ ulcerative colitis/ scleroderma
History of prior allergic reactions attributed to compounds of similar chemical or biologic composition as capecitabine
History of prior allergic reactions attributed to compounds of CT/ MRI contrast that cannot be managed with appropriate pre-medication prophylaxis and thereby preclude use of baseline/ follow-up or radiation planning imaging

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
stereotactic body radiation therapyAlso: SBRT, stereotactic radiation therapy, stereotactic radiotherapyUndergo SBRT	Radiation	Treatment (SBRT, capecitabine, and surgery)
capecitabineAlso: CAPE, Ro 09-1978/000, XelodaGiven PO	Drug	Treatment (SBRT, capecitabine, and surgery)
therapeutic conventional surgeryUndergo definitive surgery	Procedure or surgery	Treatment (SBRT, capecitabine, and surgery)
magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingOptional correlative studies	Procedure or surgery	Treatment (SBRT, capecitabine, and surgery)
laboratory biomarker analysisOptional correlative studies	Other	Treatment (SBRT, capecitabine, and surgery)

Primary outcome

Incidence of dose-limiting toxicity defined as any grade 3-4 non-hematologic toxicity or grade 5 toxicity attributable to combination chemo-radiotherapy per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 90 days from the start of SBRT and capecitabine
The number and percent of patients reporting adverse events (all, severe or worse, serious and related) will be quantified for each dose level.

6 secondary outcomes

Incidence of 30-day post-operative complications
Time frame: 30 days
Radiological response per Response Evaluation Criteria in Solid Tumors (RECIST) and volumetric measurements
Time frame: Up to 3 years
Pathological response, graded based on the College of American Pathologists (CAP) and Ishikawa, Evans, and Chun grading systems
Time frame: Up to 3 years
Incidence of margin-negative resection, defined as the absence of viable tumor cells at the inked surgical margin
Time frame: Up to 3 years
Loco-regional recurrence free survival, defined with follow-up radiological assessment
Time frame: From the point of start of SBRT to the point of recurrence or death, assessed up to 3 years
OS
Time frame: From the point of start of SBRT to the time of death or last follow-up if alive, assessed up to 3 years

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 1 Jun 2022.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.

Related trials for Stage IA Pancreatic Cancer

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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.

Michael Bassetti principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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 1 Jun 2022. 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 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?

Incidence of dose-limiting toxicity defined as any grade 3-4 non-hematologic toxicity or grade 5 toxicity attributable to combination chemo-radiotherapy per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: Up to 90 days from the start of SBRT and capecitabine). 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 NCT01918644.

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 1 Jun 2022.