Esophageal CancerPhase 2NCT01512589
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial
A Phase 2 study testing Proton Beam Therapy (PBT), Intensity Modulated Radiation Therapy (IMRT) and Questionnaires in people with Esophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Proton Beam Therapy (PBT), Intensity Modulated Radiation Therapy (IMRT) and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2012to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age >/= 18
- Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
- Potentially resectable or unresectable esophageal cancer patients
- Induction chemotherapy prior to concurrent chemoradiation allowed
- Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
- Performance status of Karnofsky Performance Scale (KPS) >/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
Show all 11Show fewer
- Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.
- Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.
- Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, Carbon Dioxide (CO2), Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, Alanine Aminotransferase (ALT) Serum Glutamic Pyruvic Transaminase (SGPT), Aspartate Aminotransferase (AST) Serum Glutamic-oxaloacetic Transaminase (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) >2,500/uL, platelets > 75,000/uL), renal (Serum creatinine </= 1.5X Upper Limit of Normal (ULN) or creatinine clearance > 50 mL/min), and liver function (bilirubin </=1.5 fold the upper limit of normal and liver enzymes < 3 fold the upper limit of normal)
- Able to communicate in the English language.
- Any patient deemed eligible for chemoradiation for esophageal cancer treatment.
Who cannot join
- Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation. However patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible.
- Pregnant or breast-feeding females
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration
- Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIB Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer
The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer.
PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.
Read the detailed description
Study Treatment:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive IMRT.
- If you are in Group 2, you will receive PBT.
You will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
Your doctor may think it is in your best interest to also receive chemotherapy while you are receiving radiation therapy. If this occurs, you will sign a separate consent form for these drugs with a full description of how they are given and the risks they may cause.
Study Visits:
Before you begin receiving radiation therapy, you will have a baseline visit. The following tests and procedures will be performed:
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
- Your performance status will be recorded.
- You will have a PET/CT or CT scan to check the status of the disease.
- You will have lung function tests
- You will complete the symptom and quality of life questionnaires.
- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.
You will then have a study visit every week while you are receiving radiation therapy. The following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Your performance status, weight, and vital signs will be recorded.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
- You will complete the symptom and quality of life questionnaires.
Length of Study:
You will receive radiation therapy for up to 28 treatments (about 5½ weeks). You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the follow-up visits.
Follow-Up:
After you stop receiving radiation therapy, there will be a 4-6 week break. During this time, you will contacted 2 times each week to complete the symptom and quality of life questionnaires. You will receive a call from an automated calling service or from the study staff at a scheduled time of your choosing. You will continue to be followed routinely during treatment and for follow-up visits and tests.
About 4-6 weeks after you stop receiving radiation therapy, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Your performance status, weight, and vital signs will be recorded.
- You will have a PET/CT scan to check the status of the disease.
- You will have lung function tests.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
- You will complete the symptom and quality of life questionnaires.
- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.
If your doctor thinks it is in your best interest after you have completed radiation therapy, you will have surgery to remove the tumor. You will sign a separate consent form that describes the procedure and its risks. As part of this study, the study doctor will check you for side effects and discomfort after the surgery.
Every 3-4 months for 2 years, and then every 4-6 months for the next 3 years, you will have follow-up visits. The following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Your performance status, weight, and vital signs will be recorded.
- You will have either a CT or a PET/CT scan to check the status of the disease.
- You will complete the symptom and quality of life questionnaires. (If the disease gets worse, these questionnaires will no longer be completed.)
Additionally, the following tests and procedures will be performed at follow-up visits only when the doctor thinks they are needed:
- Blood (about 1-2 tablespoons) may be drawn for routine tests.
- You may have lung function tests.
- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.
You may be contacted by the study staff to ask about your health, even if you choose not to return to MD Anderson for follow-up visits after completing treatment for esophageal cancer.
This is an investigational study. IMRT and PBT are delivered using FDA-approved and commercially available methods. It is investigational to compare IMRT to PBT.
Up to 180 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Esophageal Cancer
- Being tested
- Proton Beam Therapy (PBT), Intensity Modulated Radiation Therapy (IMRT), Questionnaires
- Keywords
- Proton Beam Therapy, PBT, Intensity-Modulated Radiation Therapy, IMRT, Esophageal cancer, Adenocarcinoma, Squamous cell carcinoma, Cervical esophagus, Thoracic esophagus, Gastroesophageal junction, Cardia of stomach, Questionnaires, Surveys, Symptom scores, Quality of life, QOL
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam Therapy (PBT)Radiation
Also called Radiation Therapy, XRT
1.8 Gy (Relative Biologic Equivalence ((RBE)) to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
Intensity Modulated Radiation Therapy (IMRT)Radiation
Also called Radiation Therapy, XRT
1.8 Gy to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
QuestionnairesBehavioural
Also called Surveys
Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.
| Study group | Role | What they receive |
|---|---|---|
| Proton Beam Therapy (PBT) | Experimental | Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV). Receives: Radiation: Proton Beam Therapy (PBT); Behavioral: Questionnaires |
| Intensity Modulated Radiation Therapy (IMRT) | Active comparator | Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV). Receives: Radiation: Intensity Modulated Radiation Therapy (IMRT); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined from the time of enrollment to the date of death or any recurrence. The progression-free survival (PFS) time distribution will be estimated in each treatment arm using the Kaplan-Meier method.
Measured: 6 weeks after radiation therapy
Total Toxicity Burden (TTB)
TTB defined from the time of randomization to 12 months after randomization. Total toxicity burden (TTB) is computed as a composite score from serious adverse events (SAEs) and, among patients who undergo surgery, postoperative complications (POCs).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study start30 Apr 2012
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven H. Lin, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512589
- Sponsor's protocol ID
- 2011-1036
- Other IDs
- NCI-2012-00078, 5U19CA021239
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2012
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, van Rossum PSN, Chu Y, Hobbs BP, Grassberger C, Hong TS, Liao Z, Yang J, Zhang X, Netherton T, Mohan R, Lin SH. Severe Lymphopenia During Chemoradiation Therapy for Esophageal Cancer: Comprehensive Analysis of Randomized Phase 2B Trial of Proton Beam Therapy Versus Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):368-377. doi: 10.1016/j.ijrobp.2023.08.058. Epub 2023 Aug 29.
PubMed 37652304Lin SH, Hobbs BP, Verma V, Tidwell RS, Smith GL, Lei X, Corsini EM, Mok I, Wei X, Yao L, Wang X, Komaki RU, Chang JY, Chun SG, Jeter MD, Swisher SG, Ajani JA, Blum-Murphy M, Vaporciyan AA, Mehran RJ, Koong AC, Gandhi SJ, Hofstetter WL, Hong TS, Delaney TF, Liao Z, Mohan R. Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. J Clin Oncol. 2020 May 10;38(14):1569-1579. doi: 10.1200/JCO.19.02503. Epub 2020 Mar 11.
PubMed 32160096
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIB Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01512589
- Acronym / sponsor ID
- 2011-1036
- Conditions
- Esophageal Cancer
- Keywords
- Proton Beam Therapy, PBT, Intensity-Modulated Radiation Therapy, IMRT, Esophageal cancer, Adenocarcinoma, Squamous cell carcinoma, Cervical esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 147 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Cancer Institute (NCI)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Jan 2012 (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.
The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer.
PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.
Detailed description
Study Treatment:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive IMRT.
- If you are in Group 2, you will receive PBT.
You will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.
Your doctor may think it is in your best interest to also receive chemotherapy while you are receiving radiation therapy. If this occurs, you will sign a separate consent form for these drugs with a full description of how they are given and the risks they may cause.
Study Visits:
Before you begin receiving radiation therapy, you will have a baseline visit. The following tests and procedures will be performed:
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
- Your performance status will be recorded.
- You will have a PET/CT or CT scan to check the status of the disease.
- You will have lung function tests
- You will complete the symptom and quality of life questionnaires.
- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.
You will then have a study visit every week while you are receiving radiation therapy. The following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Your performance status, weight, and vital signs will be recorded.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
- You will complete the symptom and quality of life questionnaires.
Length of Study:
You will receive radiation therapy for up to 28 treatments (about 5½ weeks). You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the follow-up visits.
Follow-Up:
After you stop receiving radiation therapy, there will be a 4-6 week break. During this time, you will contacted 2 times each week to complete the symptom and quality of life questionnaires. You will receive a call from an automated calling service or from the study staff at a scheduled time of your choosing. You will continue to be followed routinely during treatment and for follow-up visits and tests.
About 4-6 weeks after you stop receiving radiation therapy, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Your performance status, weight, and vital signs will be recorded.
- You will have a PET/CT scan to check the status of the disease.
- You will have lung function tests.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
- You will complete the symptom and quality of life questionnaires.
- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.
If your doctor thinks it is in your best interest after you have completed radiation therapy, you will have surgery to remove the tumor. You will sign a separate consent form that describes the procedure and its risks. As part of this study, the study doctor will check you for side effects and discomfort after the surgery.
Every 3-4 months for 2 years, and then every 4-6 months for the next 3 years, you will have follow-up visits. The following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Your performance status, weight, and vital signs will be recorded.
- You will have either a CT or a PET/CT scan to check the status of the disease.
- You will complete the symptom and quality of life questionnaires. (If the disease gets worse, these questionnaires will no longer be completed.)
Additionally, the following tests and procedures will be performed at follow-up visits only when the doctor thinks they are needed:
- Blood (about 1-2 tablespoons) may be drawn for routine tests.
- You may have lung function tests.
- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.
You may be contacted by the study staff to ask about your health, even if you choose not to return to MD Anderson for follow-up visits after completing treatment for esophageal cancer.
This is an investigational study. IMRT and PBT are delivered using FDA-approved and commercially available methods. It is investigational to compare IMRT to PBT.
Up to 180 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Beam Therapy (PBT) | Experimental | Radiation: Proton Beam Therapy (PBT), Behavioral: QuestionnairesRadiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV). |
| Intensity Modulated Radiation Therapy (IMRT) | Active comparator | Radiation: Intensity Modulated Radiation Therapy (IMRT), Behavioral: QuestionnairesRadiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >/= 18
- Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
- Potentially resectable or unresectable esophageal cancer patients
- Induction chemotherapy prior to concurrent chemoradiation allowed
- Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
Key exclusion criteria (4 listed)
- Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation. However patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible.
- Pregnant or breast-feeding females
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration
- Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.
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 |
|---|---|---|
| Proton Beam Therapy (PBT)Also: Radiation Therapy, XRT1.8 Gy (Relative Biologic Equivalence ((RBE)) to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. | Radiation | Proton Beam Therapy (PBT) |
| Intensity Modulated Radiation Therapy (IMRT)Also: Radiation Therapy, XRT1.8 Gy to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. | Radiation | Intensity Modulated Radiation Therapy (IMRT) |
| QuestionnairesAlso: SurveysSymptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase. | Behavioural | Intensity Modulated Radiation Therapy (IMRT), Proton Beam Therapy (PBT) |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 6 weeks after radiation therapy
Defined from the time of enrollment to the date of death or any recurrence. The progression-free survival (PFS) time distribution will be estimated in each treatment arm using the Kaplan-Meier method.
Total Toxicity Burden (TTB)
Time frame: 12 months
TTB defined from the time of randomization to 12 months after randomization. Total toxicity burden (TTB) is computed as a composite score from serious adverse events (SAEs) and, among patients who undergo surgery, postoperative complications (POCs).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Derived from this study: PubMed 37652304Wang X, van Rossum PSN, Chu Y, Hobbs BP, Grassberger C, Hong TS, Liao Z, Yang J, Zhang X, Netherton T, Mohan R, Lin SH. Severe Lymphopenia During Chemoradiation Therapy for Esophageal Cancer: Comprehensive Analysis of Randomized Phase 2B Trial of Proton Beam Therapy Versus Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):368-377. doi: 10.1016/j.ijrobp.2023.08.058. Epub 2023 Aug 29.
- Derived from this study: PubMed 32160096Lin SH, Hobbs BP, Verma V, Tidwell RS, Smith GL, Lei X, Corsini EM, Mok I, Wei X, Yao L, Wang X, Komaki RU, Chang JY, Chun SG, Jeter MD, Swisher SG, Ajani JA, Blum-Murphy M, Vaporciyan AA, Mehran RJ, Koong AC, Gandhi SJ, Hofstetter WL, Hong TS, Delaney TF, Liao Z, Mohan R. Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. J Clin Oncol. 2020 May 10;38(14):1569-1579. doi: 10.1200/JCO.19.02503. Epub 2020 Mar 11.
- M D Anderson Cancer CenterLink 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.
Steven H. Lin, MD,PHD principal investigator
M.D. Anderson Cancer Center
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 Proton Beam Therapy (PBT), Intensity Modulated Radiation Therapy (IMRT) and Questionnaires in people with Esophageal Cancer, run by M.D. Anderson Cancer Center 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 11 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Progression-Free Survival (PFS) (time frame: 6 weeks after radiation therapy). The study lists 2 primary outcomes in all. 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 NCT01512589, which also lists 2 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 6 Oct 2026.