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Chemotherapy

Vitamin C + Radiation Therapy for Pancreatic Cancer (XACT-PANC-2 Trial)

Phase 2

Waitlist Available

Led By Joseph Caster, MD, PhD

Research Sponsored by Joseph J. Cullen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Referral for gemcitabine-based chemoradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly for the first 6 weeks and then at follow-up through 5 years post-treatment

Awards & highlights

XACT-PANC-2 Trial Summary

This trial will explore if high doses of vitamin C help reduce side effects in cancer patients, and if it increases their survival rates.

Who is the study for?

This trial is for adults with pancreatic cancer who are referred for gemcitabine-based chemoradiation. They must not have other active cancers needing immediate treatment, uncontrolled illnesses, or be on certain medications like warfarin. Participants need to avoid alcohol and some supplements, have a good performance status, and agree to use birth control.Check my eligibility

What is being tested?

The study tests if high-dose vitamin C (ascorbate) can reduce side effects of radiation therapy in pancreatic cancer patients and possibly improve survival rates. Patients will receive ascorbate alongside standard gemcitabine chemotherapy and radiation therapy.See study design

What are the potential side effects?

Potential side effects may include those commonly associated with high doses of vitamin C such as digestive discomfort or kidney stones. Gemcitabine and radiation therapy can cause fatigue, nausea, skin irritation at the treatment site, low blood cell counts increasing infection risk.

XACT-PANC-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am referred for treatment combining chemotherapy with radiation.

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I can take care of myself and perform daily activities.

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I have been diagnosed with pancreatic cancer.

XACT-PANC-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly for the first 6 weeks and then at follow-up through 5 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly for the first 6 weeks and then at follow-up through 5 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for the first 6 weeks and then at follow-up through 5 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS)

Secondary outcome measures

Adverse event frequency and categorization

Metastasis free survival (MFS)

Pathologic characteristics

+5 more

Other outcome measures

Exploration of patient reported outcomes during combined therapy [qualitative string]

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597

44%

Acute RT Toxicity: Bowel: NOS

29%

Hormone Toxicity: Hot flashes : NOS

26%

Late RT Toxicity: Bowel: NOS

24%

Hormone Toxicity: Impotence : NOS

18%

Late RT Toxicity: Bladder: NOS

17%

Hormone Toxicity: Hematologic : NOS

15%

Acute RT Toxicity: Bladder: NOS

13%

Acute RT Toxicity: Hematologic: NOS

13%

Late RT Toxicity: Hematologic: NOS

13%

Acute RT Toxicity: Other: NOS

Hormone Toxicity: Liver : NOS

Late RT Toxicity: Other: NOS

Late RT Toxicity: Other GU: NOS

100%

80%

60%

40%

20%

Study treatment Arm

Neoadjuvant TAS 2 Months Before and During RT

Radiation Therapy Alone

XACT-PANC-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational Therapy (ASC)Experimental Treatment3 Interventions

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

Group II: Standard Therapy (ChemoRT)Active Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

radiation therapy

1994

Completed Phase 3

~13390

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joseph J. CullenLead Sponsor

4 Previous Clinical Trials

97 Total Patients Enrolled

Joseph J. Cullen, MD, FACSLead Sponsor

3 Previous Clinical Trials

114 Total Patients Enrolled

Holden Comprehensive Cancer CenterOTHER

26 Previous Clinical Trials

717 Total Patients Enrolled

Media Library

Pancreatic Cancer Research Study Groups: Standard Therapy (ChemoRT), Investigational Therapy (ASC)

Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03541486 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for this clinical trial?

"According to clinicaltrials.gov, this trial has concluded its recruitment process as of January 28th 2022 - the last time it was updated. Despite no longer accepting participants, there are still 1071 other trials in progress that may be of interest."

Answered by AI

How many participants are in this exploration of treatments?

"As of now, this medical trial is not enrolling any more patients. The original post was made on December 31st 2022 and the last edit happened on January 28th 2022. For individuals searching for alternative studies, there are 578 trials currently recruiting those with neoplasms in their pancreas as well as 493 radiation therapy clinical trials that are open to participants."

Answered by AI

Has there been any other research conducted on the efficacy of radiotherapy?

"Currently, 493 trials exploring the efficacy of radiation therapy are active. Of those, 142 have advanced to Phase 3 testing. Although a majority of these medical studies are based in Adelaide, South Australia, there is an expansive network of 24977 clinical trial sites across the globe conducting radiation research."

Answered by AI

In what cases is radiation therapy generally utilized?

"Radiation therapy is popularly used to address small cell lung cancer (SCLC), but can also be employed in the management of head and neck carcinoma, cervical neoplasms, and catarrh."

Answered by AI

Is radiation therapy considered a safe treatment option for those seeking care?

"Since radiation therapy has demonstrated some safety in prior clinical trials, but yet to be proven efficacious, our team at Power provisionally assessed its risk as a 2."

Answered by AI

Recent research and studies

Redox BiologyJournal

Tumor Cells Have Decreased Ability to Metabolize H2O2: Implications for Pharmacological Ascorbate in Cancer Therapy

Doskey, Claire M., Visarut Buranasudja, Brett A. Wagner, Justin G. Wilkes, Juan Du, Joseph J. Cullen, and Garry R. Buettner. 2016. “Tumor Cells Have Decreased Ability to Metabolize H2O2: Implications for Pharmacological Ascorbate in Cancer Therapy”. Redox Biology. Elsevier BV. doi:10.1016/j.redox.2016.10.010.

Current Pharmaceutical BiotechnologyJournal

Treatment of Pancreatic Cancer with Pharmacological Ascorbate

Cieslak, John, and Joseph Cullen. 2015. “Treatment of Pancreatic Cancer with Pharmacological Ascorbate”. Current Pharmaceutical Biotechnology. Bentham Science Publishers Ltd.. doi:10.2174/138920101609150715135921.

Cancer CellJournal

O 2 ⋅− and H 2 O 2 -mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate

Schoenfeld, Joshua D., Zita A. Sibenaller, Kranti A. Mapuskar, Brett A. Wagner, Kimberly L. Cramer-Morales, Muhammad Furqan, Sonia Sandhu, et al.. 2017. “O 2 ⋅− and H 2 O 2 -mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccell.2017.02.018.

Cancer Chemotherapy and PharmacologyJournal