Ductal Breast Carcinoma In SituPhase 2/3NCT03077841
Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
A Phase 2/3 study testing Laboratory Biomarker Analysis, Partial Breast Irradiation and Questionnaire Administration in people with Ductal Breast Carcinoma In Situ and Early-Stage Breast Carcinoma, run by M.D. Anderson Cancer Center at 15 sites in United States.
Trial summary
This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma In Situ, Early-Stage Breast Carcinoma, Invasive Breast Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Partial Breast Irradiation and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 928 participants
- Where
- 15 sitesUnited States
- Study dates
- 6 Mar 2017to 8 Nov 2027
- Phase
- Phase 2/3
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
- Pathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
- For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
- Treatment with breast conserving surgery
- Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
- Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
Show all 10Show fewer
- For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)
- If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
- Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy
- Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation
Who cannot join
- Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
- Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
- Systemic chemotherapy prior to final breast conserving surgery
- Patient is pregnant or nursing
- History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
- History of prior invasive or in situ cancer in either breast
- Current diagnosis of bilateral breast cancer
- History of lupus or scleroderma
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Presbyterian Hospital
Albuquerque, New Mexico, 87106
Piedmont Hospital
Atlanta, Georgia, 30309
Summit Medical Group
Berkeley Heights, New Jersey, 07922
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
MD Anderson in The Woodlands
Conroe, Texas, 77384
M D Anderson Cancer Center
Houston, Texas, 77030
MD Anderson West Houston
Houston, Texas, 77079
Community Cancer Center East
Indianapolis, Indiana, 46219
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
MD Anderson League City
League City, Texas, 77573
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
Covenant Medical Center Harrison
Saginaw, Michigan, 48602
Saint Luke's Baptist Health System
San Antonio, Texas, 78229
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043
About this study
Official title: Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen.
SECONDARY OBJECTIVES:
- To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen.
II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559.
III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer.
IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival.
- To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale.
VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.
ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.
After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.
- Conditions
- Ductal Breast Carcinoma In Situ, Early-Stage Breast Carcinoma, Invasive Breast Carcinoma, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
- Being tested
- Laboratory Biomarker Analysis, Partial Breast Irradiation, Questionnaire Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Partial Breast IrradiationRadiation
Undergo hypofractionated partial breast irradiation
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (hypofractionated partial breast irradiation) | Experimental | Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. Receives: Other: Laboratory Biomarker Analysis; Radiation: Partial Breast Irradiation; Other: Questionnaire Administration |
| Arm II (hypofractionated partial breast irradiation) | Active comparator | Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. Receives: Other: Laboratory Biomarker Analysis; Radiation: Partial Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of grade 2 or higher toxicity
Will evaluate whether or not the risk of this outcome is higher than the risk of grade 2+ toxic events in the best performing arm of our prior clinical trial that evaluated dosing schedules of whole breast irradiation (2010-0559).
Measured: At 6 months post radiation
Secondary outcomes (9)
Patient-reported cosmetic outcome
Patient-reported cosmetic outcome, functional status, and breast pain will be measured using the Breast Cancer Treatment Outcomes Scale (BCTOS) and will be compared for the IMPORT Low versus OPAL regimens. Each outcome will be evaluated both as a continuous variable and as a dichotomous variable with a cutpoint of >= 2.5, indicating a moderate or greater average change in the treated breast compared to the untreated breast which serves as an internal control. Will use descriptive statistics to summarize patient-reported cosmetic outcome, functional status, and breast pain over time. Box plots and graphical measures will be used to display the distribution of these outcomes over time and by treatment arm. Will conduct linear mixed models to assess changes in patient-reported cosmetic outcome, functional status, and breast pain scores over time. A random intercept will be included to account for within-subject correlations.
Measured: At 6 months, one year, two years, three years, four years, and five years after completing the optimizing preventative adjuvant linac-based radiation (OPAL) regimen
Physician-reported and photographically-assessed cosmetic outcome
Physician-reported cosmetic outcome, functional status, and breast pain will be measured using the Breast Cancer Treatment Outcomes Scale (BCTOS) and will be compared for the IMPORT Low versus OPAL regimens. Each outcome will be evaluated both as a continuous variable and as a dichotomous variable with a cutpoint of >= 2.5, indicating a moderate or greater average change in the treated breast compared to the untreated breast which serves as an internal control. Will use descriptive statistics to summarize patient-reported cosmetic outcome, functional status, and breast pain over time. Box plots and graphical measures will be used to display the distribution of these outcomes over time and by treatment arm. Will conduct linear mixed models to assess changes in patient-reported cosmetic outcome, functional status, and breast pain scores over time. A random intercept will be included to account for within-subject correlations.
Measured: At 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen
Risk of pathologically-confirmed invasive and/or ipsilateral breast tumor recurrence (IBTR)
Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. IBTR will be measured from the date of treatment initiation to the date of last evaluation or IBTR. The 5-year risk of IBTR and any recurrence will be estimated along with 95% confidence intervals. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes.
Measured: At 5 years
Risk of any recurrence of breast cancer
Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. Recurrence-free survival will be measured from the date of radiation treatment initiation to the earliest date of last clinic visit, date of first recurrence, or date of death. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes.
Measured: At 5 years
Disease free survival (DFS)
Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. DFS will be measured from date of treatment initiation to the earliest date of last clinic visit, date of progression, date of recurrence, date of metastasis, or date of death. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes.
Measured: At 5 years
Overall survival
Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. OS will be measured from the date of treatment initiation to the earliest date of last contact or death. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes.
Measured: At 5 years
Incidence of adverse events
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4. Differences in National Cancer Institute CTCAE and Subjective, Objective, Management, Analytic (SOMA) toxicity by treatment arm will be evaluated using chi-square test or Fisher's exact test, as appropriate.
Measured: Up to 5 years
Feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network
The trial will be considered feasible if >= 90% of enrolled and treated patients receive the prescribed radiation dosing per protocol without deviations.
Measured: 5 years
TGF-beta analysis
For this analysis, the primary outcome is grade 2 or higher breast fibrosis measured using the Subjective, Objective, Management, Analytic/Late Effects Normal Tissue Task Force scale at the 3.5 year follow up visit. The exposure of interest is the presence of at least one copy of the C-509T allele in germline deoxyribonucleic acid (DNA). Will also conduct exploratory analyses to assess the association of TGF-beta genotype with cosmetic outcome, other PROs, and toxicities. T-test or rank-sum test will be used for continuous measures and chi-squared or Fishers exact test will be used for categorical measures.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start6 Mar 2017
- Primary completion8 Nov 2027 (estimated)
- Study completion8 Nov 2027 (estimated)
Why it stopped: PI Requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ductal Breast Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 928 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Benjamin D Smith, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077841
- Sponsor's protocol ID
- 2016-1035
- Other IDs
- NCI-2017-00476, 2016-1035
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reddy JP, Lei X, Bloom ES, Reed VK, Schlembach PJ, Arzu I, Mayo L, Chun SG, Ahmad NR, Stauder MC, Gopal R, Kaiser K, Fang P, Smith BD; OPAL Trial Investigators. Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):629-644. doi: 10.1016/j.ijrobp.2022.09.083. Epub 2022 Oct 8.
PubMed 36216274
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT03077841
- Acronym / sponsor ID
- 2016-1035
- Conditions
- Ductal Breast Carcinoma In Situ, Early-Stage Breast Carcinoma, Invasive Breast Carcinoma, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI Requested
- Enrolment
- 928 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 8 Nov 2027 (estimated)
- Study completion
- 8 Nov 2027 (estimated)
- First posted
- 13 Mar 2017 (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.
This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.
Detailed description
PRIMARY OBJECTIVE:
- The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen.
SECONDARY OBJECTIVES:
- To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen.
II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559.
III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer.
IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival.
- To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale.
VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.
ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.
After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (hypofractionated partial breast irradiation) | Experimental | Other: Laboratory Biomarker Analysis, Radiation: Partial Breast Irradiation, Other: Questionnaire AdministrationPatients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. |
| Arm II (hypofractionated partial breast irradiation) | Active comparator | Other: Laboratory Biomarker Analysis, Radiation: Partial Breast IrradiationPatients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
- Pathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
- For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
- Treatment with breast conserving surgery
- Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
Key exclusion criteria (8 listed)
- Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
- Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
- Systemic chemotherapy prior to final breast conserving surgery
- Patient is pregnant or nursing
- History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (hypofractionated partial breast irradiation), Arm II (hypofractionated partial breast irradiation) |
| Partial Breast IrradiationUndergo hypofractionated partial breast irradiation | Radiation | Arm I (hypofractionated partial breast irradiation), Arm II (hypofractionated partial breast irradiation) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (hypofractionated partial breast irradiation) |
Primary outcome
Risk of grade 2 or higher toxicity
Time frame: At 6 months post radiation
Will evaluate whether or not the risk of this outcome is higher than the risk of grade 2+ toxic events in the best performing arm of our prior clinical trial that evaluated dosing schedules of whole breast irradiation (2010-0559).
9 secondary outcomes
Patient-reported cosmetic outcome
Time frame: At 6 months, one year, two years, three years, four years, and five years after completing the optimizing preventative adjuvant linac-based radiation (OPAL) regimen
Physician-reported and photographically-assessed cosmetic outcome
Time frame: At 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen
Risk of pathologically-confirmed invasive and/or ipsilateral breast tumor recurrence (IBTR)
Time frame: At 5 years
Risk of any recurrence of breast cancer
Time frame: At 5 years
Disease free survival (DFS)
Time frame: At 5 years
Overall survival
Time frame: At 5 years
Incidence of adverse events
Time frame: Up to 5 years
Feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network
Time frame: 5 years
TGF-beta analysis
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 36216274Reddy JP, Lei X, Bloom ES, Reed VK, Schlembach PJ, Arzu I, Mayo L, Chun SG, Ahmad NR, Stauder MC, Gopal R, Kaiser K, Fang P, Smith BD; OPAL Trial Investigators. Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):629-644. doi: 10.1016/j.ijrobp.2022.09.083. Epub 2022 Oct 8.
- MD AnDERSON CANCRER CENTER WEBSITELink provided by the sponsor.
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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.
Benjamin D Smith principal investigator
M.D. Anderson Cancer Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Laboratory Biomarker Analysis, Partial Breast Irradiation and Questionnaire Administration in people with Ductal Breast Carcinoma In Situ and Early-Stage Breast Carcinoma, run by M.D. Anderson Cancer Center at 15 sites 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 8 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: paused, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Risk of grade 2 or higher toxicity (time frame: At 6 months post radiation). 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 NCT03077841, which also lists 1 linked publication.
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 14 Sep 2026.