A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients (XACT-PANC-2)
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|ClinicalTrials.gov Identifier: NCT03541486|
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasm||Drug: Ascorbate Drug: Gemcitabine Radiation: radiation therapy||Phase 2|
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).
- receive pharmacological ascorbate intravenously ascorbate during their daily radiation therapy treatments. Radiation treatments are given once a day, Monday through Friday.
- have routine doctor's visits and be asked about any side effects they are experiencing.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||XACT-Pancreas 2: Pharmacological Ascorbate, Gemcitabine, and Radiation Therapy for Pancreatic Cancer, Phase 2|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 31, 2029|
|Estimated Study Completion Date :||December 31, 2030|
Experimental: Concomitant Therapy
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
75 gram infusion daily (M-F) on days when radiation therapy is administered
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.
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541486
|Contact: Joseph J. Cullen, MD, FACS||(319) firstname.lastname@example.org|
|Contact: Bryan G. Allen, MD, PhD||(319) email@example.com|
|United States, Iowa|
|The University of Iowa||Not yet recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sandy Vollstedt, RN, BSN, OCN 319-353-7143 firstname.lastname@example.org|
|Contact: Heather Brown, RN, BAN, OCN 319-384-7912 email@example.com|
|Principal Investigator:||Joseph J. Cullen, MD, FACS||University of Iowa|