Pancreatic NeoplasmPhase 2XACT-PANC-2NCT03541486
A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients
A Phase 2 study testing Ascorbate, Gemcitabine and radiation therapy in people with Pancreatic Neoplasm, run by Joseph J. Cullen, MD, FACS at 1 site in United States.
Trial summary
Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Ascorbate, Gemcitabine and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2025to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Referral for gemcitabine-based chemoradiation
Show all 10Show fewer
- Good performance status (ECOG of 0, 1, or 2; KPS of > 50)
- No other active malignancy that requires immediate treatment. Slow growing concurrent cancers (such as prostate cancer) are acceptable with appropriate documentation from their treating oncologists for that primary.
- 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
Who cannot join
- 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)
- Presence of metastatic disease beyond regional lymphatics
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XACT-Pancreas 2: Pharmacological Ascorbate, Gemcitabine, and Radiation Therapy for Pancreatic Cancer, Phase 2
Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.
Read the detailed description
This is a randomized phase 2 study is designed to determine initial efficacy and assess adverse events, and quantify pathologic evidence of intestinal radiation injury. 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:
- be randomized (like flipping a coin) to receive the investigational treatment (pharmacological ascorbate plus gemcitabine plus radiation) or standard treatment only (gemcitabine plus radiation)
- 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).
- be interviewed to discuss their side effects, how it impacts their life, and describe their recent activities.
- receive pharmacological ascorbate intravenously ascorbate during their daily radiation therapy treatments (if randomized to receive the investigational treatment).
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. We are interested in the long-term side effects of radiation - which may not develop for years - so it is important the participant return to radiation oncology for follow-up. We will also conduct interviews at that time to review the side effects and how they impact the participant's quality of life.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Ascorbate, Gemcitabine, radiation therapy
- Keywords
- ascorbic acid, ascorbate, sodium ascorbate, radiotherapy, radiotherapy, image-guided, gemcitabine, adverse event, quality of life, radiation enteropathy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AscorbateDrug
Also called Ascor L 500, Pharmacological ascorbate, Vitamin C
75 gram infusion daily (M-F) on days when radiation therapy is administered. The infusion occurs during the 'beam on' of the radiation therapy.
GemcitabineDrug
Also called Gemzar
600 mg/m2 once weekly for up to weeks
radiation therapyRadiation
Also called Volumetric Arc Therapy (VMAT), External beam radiation therapy
Prescribed to 50 Gy in 25 fractions. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Therapy (ASC) | Experimental | 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 Receives: Drug: Ascorbate; Drug: Gemcitabine; Radiation: radiation therapy |
| Standard Therapy (ChemoRT) | Active comparator | 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 Receives: Drug: Gemcitabine; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
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
Measured: Up to 5 years post treatment
Secondary outcomes (8)
Progression free survival (PFS)
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.
Measured: Up to 5 years post-treatment
Toxicity over time (ToxT)
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.
Measured: Treatment day 1 to 30 days post-treatment
Metastasis free survival (MFS)
time from treatment initiation (day 1) to the date of first documentation of disease progression outside of the pelvis (per RECIST 1.1)
Measured: Up to 5 years post-treatment
Resection rate
Rate of patients who undergo resection of tumor
Measured: Within 2 month post-radiation
Adverse event frequency and categorization
Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 5)
Measured: Weekly for the first 6 weeks and then at follow-up through 5 years post-treatment
Patient reported outcome measure: Vaizey Incontinence questionnaire
Patient reported outcome measure of bowel side effects collected at pre-specified timepoints.
Measured: Treatment day 1 to 5 years post-treatment
Quality of life: Modified Inflammatory Bowel Disease questionnaire
Patient completed quality of life form collected at pre-specified timepoints.
Measured: Treatment day 1 to 5 years post-treatment
Pathologic characteristics
- Mucosal ulcerations, inflammatory cell infiltration, collage deposition, and microvascular changes will be assessed
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial (standard vs. experimental) in a one-to-one ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph J. Cullen, MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center
- Responsible party
- Principal investigator, Joseph Caster, Ph.D., M.D., University of Iowa
- Investigators
- Joseph Caster, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541486
- Sponsor's protocol ID
- XACT-PANC-2
- Acronym
- XACT-PANC-2
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2018
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, including endpoints (OS, PFS, MFS, AE, and PROs), treatment information, coding, code book, and demographics.
Publications
Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
PubMed 28366679Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.
PubMed 23381814Doskey CM, Buranasudja V, Wagner BA, Wilkes JG, Du J, Cullen JJ, Buettner GR. Tumor cells have decreased ability to metabolize H2O2: Implications for pharmacological ascorbate in cancer therapy. Redox Biol. 2016 Dec;10:274-284. doi: 10.1016/j.redox.2016.10.010. Epub 2016 Oct 28.
PubMed 27833040Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.
PubMed 26201606Alexander MS, Wilkes JG, Schroeder SR, Buettner GR, Wagner BA, Du J, Gibson-Corley K, O'Leary BR, Spitz DR, Buatti JM, Berg DJ, Bodeker KL, Vollstedt S, Brown HA, Allen BG, Cullen JJ. Pharmacologic Ascorbate Reduces Radiation-Induced Normal Tissue Toxicity and Enhances Tumor Radiosensitization in Pancreatic Cancer. Cancer Res. 2018 Dec 15;78(24):6838-6851. doi: 10.1158/0008-5472.CAN-18-1680. Epub 2018 Sep 25.
PubMed 30254147
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XACT-Pancreas 2: Pharmacological Ascorbate, Gemcitabine, and Radiation Therapy for Pancreatic Cancer, Phase 2
- ClinicalTrials.gov ID
- NCT03541486
- Acronym / sponsor ID
- XACT-PANC-2 / XACT-PANC-2
- Conditions
- Pancreatic Neoplasm
- Keywords
- ascorbic acid, ascorbate, sodium ascorbate, radiotherapy, radiotherapy, image-guided, gemcitabine, adverse event, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joseph J. Cullen, MD, FACSUniversity, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.
Detailed description
This is a randomized phase 2 study is designed to determine initial efficacy and assess adverse events, and quantify pathologic evidence of intestinal radiation injury. 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:
- be randomized (like flipping a coin) to receive the investigational treatment (pharmacological ascorbate plus gemcitabine plus radiation) or standard treatment only (gemcitabine plus radiation)
- 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).
- be interviewed to discuss their side effects, how it impacts their life, and describe their recent activities.
- receive pharmacological ascorbate intravenously ascorbate during their daily radiation therapy treatments (if randomized to receive the investigational treatment).
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. We are interested in the long-term side effects of radiation - which may not develop for years - so it is important the participant return to radiation oncology for follow-up. We will also conduct interviews at that time to review the side effects and how they impact the participant's quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial (standard vs. experimental) in a one-to-one ratio.
| Arm | Type | Receives |
|---|---|---|
| Investigational Therapy (ASC) | Experimental | Drug: Ascorbate, Drug: Gemcitabine, Radiation: radiation therapy75 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 |
| Standard Therapy (ChemoRT) | Active comparator | Drug: Gemcitabine, Radiation: radiation therapy600 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AscorbateAlso: Ascor L 500, Pharmacological ascorbate, Vitamin C75 gram infusion daily (M-F) on days when radiation therapy is administered. The infusion occurs during the 'beam on' of the radiation therapy. | Drug | Investigational Therapy (ASC) |
| GemcitabineAlso: Gemzar600 mg/m2 once weekly for up to weeks | Drug | Investigational Therapy (ASC), Standard Therapy (ChemoRT) |
| radiation therapyAlso: Volumetric Arc Therapy (VMAT), External beam radiation therapyPrescribed to 50 Gy in 25 fractions. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks. | Radiation | Investigational Therapy (ASC), Standard Therapy (ChemoRT) |
Primary outcome
Overall survival (OS)
Time frame: Up to 5 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
8 secondary outcomes
Progression free survival (PFS)
Time frame: Up to 5 years post-treatment
Toxicity over time (ToxT)
Time frame: Treatment day 1 to 30 days post-treatment
Metastasis free survival (MFS)
Time frame: Up to 5 years post-treatment
Resection rate
Time frame: Within 2 month post-radiation
Adverse event frequency and categorization
Time frame: Weekly for the first 6 weeks and then at follow-up through 5 years post-treatment
Patient reported outcome measure: Vaizey Incontinence questionnaire
Time frame: Treatment day 1 to 5 years post-treatment
Quality of life: Modified Inflammatory Bowel Disease questionnaire
Time frame: Treatment day 1 to 5 years post-treatment
Pathologic characteristics
Time frame: At surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 28366679Schoenfeld JD, Sibenaller ZA, Mapuskar KA, Wagner BA, Cramer-Morales KL, Furqan M, Sandhu S, Carlisle TL, Smith MC, Abu Hejleh T, Berg DJ, Zhang J, Keech J, Parekh KR, Bhatia S, Monga V, Bodeker KL, Ahmann L, Vollstedt S, Brown H, Shanahan Kauffman EP, Schall ME, Hohl RJ, Clamon GH, Greenlee JD, Howard MA, Schultz MK, Smith BJ, Riley DP, Domann FE, Cullen JJ, Buettner GR, Buatti JM, Spitz DR, Allen BG. O2⋅- and H2O2-Mediated Disruption of Fe Metabolism Causes the Differential Susceptibility of NSCLC and GBM Cancer Cells to Pharmacological Ascorbate. Cancer Cell. 2017 Apr 10;31(4):487-500.e8. doi: 10.1016/j.ccell.2017.02.018. Epub 2017 Mar 30.
- Background: PubMed 23381814Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.
- Background: PubMed 27833040Doskey CM, Buranasudja V, Wagner BA, Wilkes JG, Du J, Cullen JJ, Buettner GR. Tumor cells have decreased ability to metabolize H2O2: Implications for pharmacological ascorbate in cancer therapy. Redox Biol. 2016 Dec;10:274-284. doi: 10.1016/j.redox.2016.10.010. Epub 2016 Oct 28.
- Background: PubMed 26201606Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.
- Background: PubMed 30254147Alexander MS, Wilkes JG, Schroeder SR, Buettner GR, Wagner BA, Du J, Gibson-Corley K, O'Leary BR, Spitz DR, Buatti JM, Berg DJ, Bodeker KL, Vollstedt S, Brown HA, Allen BG, Cullen JJ. Pharmacologic Ascorbate Reduces Radiation-Induced Normal Tissue Toxicity and Enhances Tumor Radiosensitization in Pancreatic Cancer. Cancer Res. 2018 Dec 15;78(24):6838-6851. doi: 10.1158/0008-5472.CAN-18-1680. Epub 2018 Sep 25.
- Individual participant dataSharing planned: Yes. All collected IPD, including endpoints (OS, PFS, MFS, AE, and PROs), treatment information, coding, code book, and demographics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Caster, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbate, Gemcitabine and radiation therapy in people with Pancreatic Neoplasm, run by Joseph J. Cullen, MD, FACS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 5 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541486, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.