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A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients (XACT-PANC-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541486
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Joseph J. Cullen, University of Iowa

Tracking Information
First Submitted Date  ICMJE April 29, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date April 8, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Overall survival (OS) [ Time Frame: Up to 10 years post treatment ]
The study will determine the time (calculated in months) between study day 1 and death from any cause. After 10 years post-treatment, dates will be censored to date of last follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • Objective response rate (ORR) [ Time Frame: 12 and 24 months post-treatment ]
    Objective response rate is defined as the number of partial response and complete response outcomes in the intent-to-treat population (partial and complete response are defined using the Response Evaluation Criteria in Solid Tumors (RECIST)).
  • Progression free survival (PFS) [ Time Frame: Up to 10 years post-treatment ]
    From radiation day 1 to documented disease progression in CT imaging as described by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Measured in months.
  • Toxicity over time (ToxT) [ Time Frame: Treatment day 1 to 30 days post-treatment ]
    Toxicity over time will be assessed by summarizing treatment emergent adverse events by system organ class and/or preferred term, type of adverse event, and severity. Elapsed days of toxicity will be summarized.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 6, 2020)
  • Exploration of patient reported outcomes during combined therapy [quantitative string] [ Time Frame: During treatment phase (approximately 7 weeks) ]
    Patient completed quality of life (EORTC QLQ C-30 form) and symptom score forms (NCI's PRO-CTCAE) collected weekly.
  • Exploration of patient reported outcomes during combined therapy [qualitative string] [ Time Frame: During treatment phase and up to 60 days after completing treatment ]
    Semi-structure focus group or one-on-one interviews for thematic analysis
Original Other Pre-specified Outcome Measures
 (submitted: May 22, 2018)
Exploration of patient reported outcomes during combined therapy [ Time Frame: During treatment phase (approximately 7 weeks) ]
Patient completed quality of life (EORTC QLQ C-30 form) and symptom score forms (NCI's PRO-CTCAE) collected weekly.
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients
Official Title  ICMJE XACT-Pancreas 2: Pharmacological Ascorbate, Gemcitabine, and Radiation Therapy for Pancreatic Cancer, Phase 2
Brief Summary This is a phase 2 study testing the initial efficacy of adding pharmacological ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.
Detailed Description

This phase 2 study is designed to determine the efficacy of adding pharmacological ascorbate (vitamin C) to standard chemoradiation. The ascorbate is infused before, during, and after the external beam radiation therapy treatment. Each ascorbate infusion is 75 grams (roughly the same amount of vitamin C from 1,000 oranges).

For patients eligible for this trial, standard treatment for their cancer includes radiation therapy combined with weekly gemcitabine (a chemotherapy).

Participants will:

  • decide if they want to receive the investigational treatment (pharmacological ascorbate plus gemcitabine plus radiation) or standard treatment only (gemcitabine plus radiation)
  • receive pharmacological ascorbate intravenously ascorbate during their daily radiation therapy treatments, if they choose the investigational treatment.
  • receive gemcitabine (a chemotherapy) once a week for up to 6 weeks of therapy (all participants)
  • receive radiation treatments are given once a day, Monday through Friday (all participants).
  • have routine doctor's visits and be asked about any side effects they are experiencing (all participants).

This is a phase 2 study to determine the effect, if any, adding pharmacological ascorbate will have on standard therapy for pancreatic cancer. The study will also record any side effects of adding ascorbate to standard therapy. Once the patient completes radiation, the ascorbate infusions are also completed. However, the patient will need to return for regular follow-up care at University of Iowa.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The trial participant will determine their treatment assignment (standard vs. experimental)
Masking: Single (Outcomes Assessor)
Masking Description:
Radiologic measurements will be completed by a reviewer blinded to treatment assignment
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neoplasm
Intervention  ICMJE
  • Drug: Ascorbate
    75 gram infusion daily (M-F) on days when radiation therapy is administered
    Other Names:
    • Ascor L 500
    • Pharmacological ascorbate
    • Vitamin C
  • Drug: Gemcitabine
    600 mg/m2 once weekly for 6 weeks
    Other Name: Gemzar
  • Radiation: radiation therapy
    Prescribed to either 50 Gy in 25 fractions or at least 50.4 Gy in 28 fractions, based on tumor. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
    Other Names:
    • Volumetric Arc Therapy (VMAT)
    • External beam radiation therapy
Study Arms  ICMJE
  • Experimental: Investigational Therapy (ASC)
    75 grams of pharmacological ascorbate, daily (M-F) 600 mg/m2 of gemcitabine, once a week for up to 6 weeks 50 to 50.4 Gray of radiation therapy delivered using a volumetric arc therapy (VMAT) technique
    Interventions:
    • Drug: Ascorbate
    • Drug: Gemcitabine
    • Radiation: radiation therapy
  • Active Comparator: Standard Therapy (ChemoRT)
    600 mg/m2 of gemcitabine, once a week for up to 6 weeks 50 to 50.4 Gray of radiation therapy delivered using a volumetric arc therapy (VMAT) technique
    Interventions:
    • Drug: Gemcitabine
    • Radiation: radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
35
Estimated Study Completion Date  ICMJE December 31, 2030
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet ALL of the following criteria:

  • Ability and willingness to provide informed consent (power of attorney and legally authorized representatives are not accepted for informed consent)
  • Stated willingness to comply with all study procedures and availability for duration of the study
  • At least 18 years of age
  • Histologic or cytologic diagnosis of pancreatic adenocarcinoma
  • Recommended to receive gemcitabine-based chemoradiation
  • Good performance status (ECOG of 0, 1, or 2; KPS of > 50)
  • No other active malignancy that requires immediate treatment. Low grown concurrent cancers are acceptable with the appropriate documentation from the treating oncologists for that additional primary disease.
  • Not experiencing an uncontrolled illness such as infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other condition that would limit compliance with the study requirements or unacceptably increase risk to the participant (as determined by study team members).
  • Agree to abstain from alcohol and specified over the counter supplements during study treatment

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participating in this study:

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • HIV positive individuals requiring anti-retroviral drug therapy (high-dose ascorbate is known to interact with many of these drugs)
  • Platelet count of <100,000 k/mm3
  • Prior radiation that would result in field overlap (this will be determined by the study's radiation oncologist)
  • Actively receiving insulin
  • Other therapy (including radiation therapy) within 2 calendar weeks of study therapy
  • On any of the following drugs and cannot or will not accept a drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide
  • Other investigational agents (PET or SPECT imaging agents are acceptable)
  • Other investigational therapy with the intention to treat the disease under study
  • Pregnancy
  • Individuals declining to use acceptable birth control during the duration of the study
  • Lactating women who decline to discontinue breastfeeding their child (women may withhold breast feeding and resume under the direction of their medical oncologist after completion of study)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joseph J. Cullen, MD, FACS (319) 353-8297 joseph-cullen@uiowa.edu
Contact: Bryan G. Allen, MD, PhD (319) 356-3693 bryan-allen@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03541486
Other Study ID Numbers  ICMJE XACT-PANC-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected IPD, including endpoints (OS, ORR, PFS, AE, and PROs), treatment information, and demographics.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Study protocol and consent will be shared after primary completion. Statistical analysis plan will be shared with results reporting. Data are available upon request and will be available for 2 years after the withdraw of the IND.
Access Criteria: An IRB-stamped signed usage agreement will be required in addition to a data sharing agreement between the academic centers. Interested researchers should contact Dr. Cullen or Dr. Allen.
Responsible Party Joseph J. Cullen, University of Iowa
Study Sponsor  ICMJE Joseph J. Cullen
Collaborators  ICMJE Holden Comprehensive Cancer Center
Investigators  ICMJE
Principal Investigator: Joseph J. Cullen, MD, FACS University of Iowa
PRS Account University of Iowa
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP