← Back to Search

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
Must not have
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)
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

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am referred for treatment combining chemotherapy with radiation.
Select...
I can take care of myself and perform daily activities.
Select...
I have been diagnosed with pancreatic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have G6PD deficiency.
Select...
I am HIV positive and on anti-retroviral therapy.
Select...
I am taking a medication that cannot be changed, such as warfarin or methadone.
Select...
I am currently using insulin.
Select...
My cancer has spread beyond the nearby lymph nodes.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS)
Secondary study objectives
Adverse event frequency and categorization
Metastasis free survival (MFS)
Pathologic characteristics
+5 more
Other study objectives
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
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone

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
Ascorbate
2019
Completed Phase 2
~30
Gemcitabine
2017
Completed Phase 3
~1920
radiation therapy
1994
Completed Phase 3
~13390

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
707 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
~40 spots leftby Dec 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top