Pancreatic NeoplasmsPhase 1NCT01852890
Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
A Phase 1 study testing Ascorbate, Gemcitabine and Radiation therapy in people with Pancreatic Neoplasms, run by Joseph J. Cullen at 1 site in United States.
Trial summary
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 14 Oct 2025
- Phase
- Phase 1
- 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
- Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma. Documentation of disease extent by CT scan is required. Radiologically measurable disease is not required.
- Age ≥ 18 years
- ECOG performance status 0, 1, or 2 (Karnofsky > 50%).
- A complete blood count and differential must be obtained within 21 days prior to radiation fraction 1, with adequate bone marrow functions as defined below:
- Absolute neutrophil count (ANC) ≥ 1500 cells per mm3
- Platelets ≥ 100,000 per mm3
Show all 16Show fewer
- Leukocytes ≥ 3,000 per mm3
- Serum blood chemistries within 21 days of radiation fraction 1, as defined below:
- Creatinine ≤ 1.5 x UIHC upper limit of normal or creatinine clearance of at least 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Total bilirubin ≤ 2 x UIHC upper limit of normal
- ALT ≤ 2.5 times the UIHC upper limit of normal
- AST ≤ 2.5 times the UIHC upper limit of normal
- PT/INR within normal limits (UIHC)
- Tolerate one test dose (15g) of ascorbate.
- Not pregnant.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Prior abdominal radiotherapy that would result in overlap of fields. The treating radiation oncologist should review prior RT fields as available.
- Adjuvant therapy (including radiation therapy) within 2 calendar weeks. Toxicities from prior therapy for the malignancy should resolve to grade 1 or less.
- Patients actively receiving insulin are excluded.
- Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbate may affect urine acidification and, as a result, may affect clearance rates of these drugs.
- Second malignancy other than non-melanoma skin cancers within the past 5 years.
Show all 10Show fewer
- Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
- Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.
- Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs. A clinical trial designed to address these interaction issues is more appropriate than this phase 1 study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.
Read the detailed description
This phase 1 study will test the safety of adding high dose ascorbate (vitamin C) to standard chemoradiation. The ascorbate is infused during external beam radiation therapy treatment.
For patients eligible for this trial, standard treatment for their cancer includes radiation therapy combined with weekly gemcitabine (a chemotherapy).
Participants will:
- receive high doses of intravenous (IV) 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 1 study that will evaluate the side effects of adding ascorbate to standard therapy. The dose given to a participant will be determined by how well other participants have tolerated ascorbate.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Ascorbate, Gemcitabine, Radiation therapy
- Keywords
- Ascorbate, Vitamin C, Radiation, Gemcitabine, Ascorbic Acid
- 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 Ascorbic Acid, Vitamin C
Intravenous infusion of high-dose ascorbate
GemcitabineDrug
Also called Gemzar
Intravenous chemotherapeutic
Radiation therapyRadiation
Also called External beam radiation therapy, Intensity modulated radiation therapy, IMRT
| Study group | Role | What they receive |
|---|---|---|
| 50g Ascorbate | Experimental | This arm is the initial starting dose. The first study participant will be assigned the 50g ascorbate arm.
* Radiation: 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.
* Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
* Ascorbate: 50 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. Receives: Drug: Ascorbate; Drug: Gemcitabine; Radiation: Radiation therapy |
| 75g Ascorbate | Experimental | If the 50g arm is tolerated, the study opens the 75g arm.
* Radiation: 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.
* Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
* Ascorbate: 75 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. Receives: Drug: Ascorbate; Drug: Gemcitabine; Radiation: Radiation therapy |
| 100g Ascorbate | Experimental | If the 75g arm is tolerated, the study opens the 100g arm.
* Radiation: 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.
* Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
* Ascorbate: 100 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. Receives: Drug: Ascorbate; Drug: Gemcitabine; Radiation: Radiation therapy |
| 25g Ascorbate | Experimental | This study arm will only be used if participants cannot tolerate the 50g arm. If participants cannot tolerate 50 grams of Ascorbate, the 25g arm is opened.
* Radiation: 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.
* Gemcitabine: 600 mg/m2, once weekly for 6 weeks.
* Ascorbate: 25 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. Receives: Drug: Ascorbate; Drug: Gemcitabine; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grade 3, 4, & 5 adverse events during radiation
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
Measured: Weekly during therapy for up to 10 weeks
Secondary outcomes (3)
Time to progression
Time from the start of therapy (radiation day 1) to documented disease progression as described by RECIST.
Measured: Monthly, up to 10 years post-treatment
Overall survival
From start of treatment (radiation day 1) until the date of death from any cause.
Measured: Monthly, up to 10 years post-treatment
Number of grade 3, 4, & 5 adverse events post-treatment
Beginning one month after completing radiation therapy, grade 3 and higher adverse events will be assessed. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
Measured: every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startJan 2014
- Primary completion22 Jan 2019
- Study completion14 Oct 2025
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 NeoplasmsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph J. Cullen
- Sponsor type
- University, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, Gateway for Cancer Research
- Responsible party
- Sponsor-investigator, Joseph J. Cullen, University of Iowa
- Investigators
- Joseph J Cullen, MD, FACS, Principal investigator, The University of Iowa Hospitals & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852890
- Sponsor's protocol ID
- 201310772
- Status last verified
- Oct 2025
- First submitted
- 3 May 2013
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.
Publications
Welsh 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 23381814Du J, Cullen JJ, Buettner GR. Ascorbic acid: chemistry, biology and the treatment of cancer. Biochim Biophys Acta. 2012 Dec;1826(2):443-57. doi: 10.1016/j.bbcan.2012.06.003. Epub 2012 Jun 20.
PubMed 22728050Cullen JJ. Ascorbate induces autophagy in pancreatic cancer. Autophagy. 2010 Apr;6(3):421-2. doi: 10.4161/auto.6.3.11527. Epub 2010 Apr 15.
PubMed 20400857Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.
PubMed 20068072Alexander 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 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine, Ascorbate, Radiation Therapy for Pancreatic Cancer, Phase I
- ClinicalTrials.gov ID
- NCT01852890
- Acronym / sponsor ID
- 201310772
- Conditions
- Pancreatic Neoplasms
- Keywords
- Ascorbate, Vitamin C, Radiation, Gemcitabine, Ascorbic Acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Joseph J. CullenUniversity, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, Gateway for Cancer Research
- Study start
- Jan 2014 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 14 May 2013 (estimated)
- 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.
This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.
Detailed description
This phase 1 study will test the safety of adding high dose ascorbate (vitamin C) to standard chemoradiation. The ascorbate is infused during external beam radiation therapy treatment.
For patients eligible for this trial, standard treatment for their cancer includes radiation therapy combined with weekly gemcitabine (a chemotherapy).
Participants will:
- receive high doses of intravenous (IV) 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 1 study that will evaluate the side effects of adding ascorbate to standard therapy. The dose given to a participant will be determined by how well other participants have tolerated ascorbate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50g Ascorbate | Experimental | Drug: Ascorbate, Drug: Gemcitabine, Radiation: Radiation therapyThis arm is the initial starting dose. The first study participant will be assigned the 50g ascorbate arm. * Radiation: 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. * Gemcitabine: 600 mg/m2, once weekly for 6 weeks. * Ascorbate: 50 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. |
| 75g Ascorbate | Experimental | Drug: Ascorbate, Drug: Gemcitabine, Radiation: Radiation therapyIf the 50g arm is tolerated, the study opens the 75g arm. * Radiation: 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. * Gemcitabine: 600 mg/m2, once weekly for 6 weeks. * Ascorbate: 75 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. |
| 100g Ascorbate | Experimental | Drug: Ascorbate, Drug: Gemcitabine, Radiation: Radiation therapyIf the 75g arm is tolerated, the study opens the 100g arm. * Radiation: 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. * Gemcitabine: 600 mg/m2, once weekly for 6 weeks. * Ascorbate: 100 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. |
| 25g Ascorbate | Experimental | Drug: Ascorbate, Drug: Gemcitabine, Radiation: Radiation therapyThis study arm will only be used if participants cannot tolerate the 50g arm. If participants cannot tolerate 50 grams of Ascorbate, the 25g arm is opened. * Radiation: 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. * Gemcitabine: 600 mg/m2, once weekly for 6 weeks. * Ascorbate: 25 grams administered intravenously (by IV) during radiation therapy, for approximately 5 to 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma. Documentation of disease extent by CT scan is required. Radiologically measurable disease is not required.
- Age ≥ 18 years
- ECOG performance status 0, 1, or 2 (Karnofsky > 50%).
- A complete blood count and differential must be obtained within 21 days prior to radiation fraction 1, with adequate bone marrow functions as defined below:
- Serum blood chemistries within 21 days of radiation fraction 1, as defined below:
Key exclusion criteria (10 listed)
- G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Prior abdominal radiotherapy that would result in overlap of fields. The treating radiation oncologist should review prior RT fields as available.
- Adjuvant therapy (including radiation therapy) within 2 calendar weeks. Toxicities from prior therapy for the malignancy should resolve to grade 1 or less.
- Patients actively receiving insulin are excluded.
- Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbate may affect urine acidification and, as a result, may affect clearance rates of these drugs.
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: Ascorbic Acid, Vitamin CIntravenous infusion of high-dose ascorbate | Drug | 100g Ascorbate, 25g Ascorbate, 50g Ascorbate, 75g Ascorbate |
| GemcitabineAlso: GemzarIntravenous chemotherapeutic | Drug | 100g Ascorbate, 25g Ascorbate, 50g Ascorbate, 75g Ascorbate |
| Radiation therapyAlso: External beam radiation therapy, Intensity modulated radiation therapy, IMRT | Radiation | 100g Ascorbate, 25g Ascorbate, 50g Ascorbate, 75g Ascorbate |
Primary outcome
Number of grade 3, 4, & 5 adverse events during radiation
Time frame: Weekly during therapy for up to 10 weeks
Assess grade 3 and higher adverse events. Evaluate the frequency and severity against the published literature to determine the likely causality between ascorbate and the adverse event(s).
3 secondary outcomes
Time to progression
Time frame: Monthly, up to 10 years post-treatment
Overall survival
Time frame: Monthly, up to 10 years post-treatment
Number of grade 3, 4, & 5 adverse events post-treatment
Time frame: every 3 months for 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- 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 22728050Du J, Cullen JJ, Buettner GR. Ascorbic acid: chemistry, biology and the treatment of cancer. Biochim Biophys Acta. 2012 Dec;1826(2):443-57. doi: 10.1016/j.bbcan.2012.06.003. Epub 2012 Jun 20.
- Background: PubMed 20400857Cullen JJ. Ascorbate induces autophagy in pancreatic cancer. Autophagy. 2010 Apr;6(3):421-2. doi: 10.4161/auto.6.3.11527. Epub 2010 Apr 15.
- Background: PubMed 20068072Du J, Martin SM, Levine M, Wagner BA, Buettner GR, Wang SH, Taghiyev AF, Du C, Knudson CM, Cullen JJ. Mechanisms of ascorbate-induced cytotoxicity in pancreatic cancer. Clin Cancer Res. 2010 Jan 15;16(2):509-20. doi: 10.1158/1078-0432.CCR-09-1713. Epub 2010 Jan 12.
- Results publication: 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. Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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 J Cullen, MD, FACS principal investigator
The University of Iowa Hospitals & Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ascorbate, Gemcitabine and Radiation therapy in people with Pancreatic Neoplasms, run by Joseph J. Cullen 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 16 inclusion and 10 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: finished, as of the sponsor's last update on 24 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of grade 3, 4, & 5 adverse events during radiation (time frame: Weekly during therapy for up to 10 weeks). 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 NCT01852890, 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 24 Oct 2025.