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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

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

No Placebo-Only Group

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have G6PD deficiency.

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I am HIV positive and on anti-retroviral therapy.

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I am taking a medication that cannot be changed, such as warfarin or methadone.

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I am currently using insulin.

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My cancer has spread beyond the nearby lymph nodes.

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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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