Esophageal Squamous Cell CarcinomaPhase 1NCT02023541
Proton Beam Therapy to Treat Esophageal Cancer
A Phase 1 study testing Proton beam therapy in people with Esophageal Squamous Cell Carcinoma and Adenocarcinoma Of Esophagus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Assess progression-free survival and overall survival of proton beam therapy (PBT) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of PBT for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of PBT for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus
- What is being tested?
- Proton beam therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2015
- 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
- Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
- Staged by PET/CT and esophagogastroduodenoscopy (EGD) OR CT w/contrast and EGD to have stage II or III disease. Endoscopic ultrasound (EUS) is encouraged but not required.
- Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer is eligible, irrespective of margin status.
- Induction chemotherapy prior to concurrent chemoradiation is allowed.
- Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.
- At least 18 years of age.
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- ECOG performance status ≤ 2 (Karnofsky > 60%)
- Normal bone marrow and organ function as defined below:
- WBC > 2,500/mcL
- Platelets ≥ 75,000/mcl
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine ≤1.5 x IULN OR creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
- English speaker.
- Financial coverage for proton therapy.
Who cannot join
- Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
- Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase I Study of Proton Beam Therapy in the Treatment of Esophageal Cancer
Assess progression-free survival and overall survival of proton beam therapy (PBT) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of PBT for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of PBT for esophageal cancer.
- Being tested
- Proton beam therapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton beam therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Resectable disease | Other | Patients with resectable disease will undergo treatment with proton beam therapy. Receives: Radiation: Proton beam therapy |
| Unresectable disease | Other | Patients with unresectable disease will undergo treatment with proton beam therapy. Receives: Radiation: Proton beam therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer.
PFS will be assessed using the Kaplan-Meier estimate.
Measured: 5 years
Overall survival
Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer.
OS will be assessed using the Kaplan-Meier estimate.
Measured: 5 years
Progression-free survival
Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer.
PFS will be assessed using the Kaplan-Meier estimate.
Measured: 2 years
Overall survival
Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer.
OS will be assessed using the Kaplan-Meier estimate.
Measured: 2 years
Secondary outcomes (3)
Patient-reported outcomes of PBT for esophageal cancer at 12 months following chemoradiation.
We will calculate descriptive statistics (mean, standard deviation, etc.) for all QOL data (EQ-5D, SF-12) in addition to other PROs (depressive symptoms, social support) at each evaluation period. Univariate tests will explore the associations among QOL and PROs using analysis of variance (ANOVA) and Fisher's exact test for correlation. Changes over time in QOL and PROs will be analyzed utilizing repeated-measures modeling techniques (repeated measures analysis of covariance).
Measured: 1 year
Quality of life
Patient-reported outcomes of proton beam therapy (PBT) for esophageal cancer at 6 months following chemoradiation
We will calculate descriptive statistics (mean, standard deviation, etc.) for all QOL data (EQ-5D, SF-12) in addition to other PROs (depressive symptoms, social support) at each evaluation period. Univariate tests will explore the associations among QOL and PROs using analysis of variance (ANOVA) and Fisher's exact test for correlation. Changes over time in QOL and PROs will be analyzed utilizing repeated-measures modeling techniques (repeated measures analysis of covariance).
Measured: 6 months
Toxicity
We will compare the proportion of ≥Grade 3 gastrointestinal or pulmonary toxicity events against historical controls utilizing Binomial tests for proportion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Lack of insurance coverage for proton beam treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Bradley, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023541
- Sponsor's protocol ID
- 201310084
- Status last verified
- Apr 2015
- First submitted
- 23 Dec 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Proton Beam Therapy in the Treatment of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02023541
- Acronym / sponsor ID
- 201310084
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of insurance coverage for proton beam treatment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Dec 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.
Assess progression-free survival and overall survival of proton beam therapy (PBT) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of PBT for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of PBT for esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable disease | Other | Radiation: Proton beam therapyPatients with resectable disease will undergo treatment with proton beam therapy. |
| Unresectable disease | Other | Radiation: Proton beam therapyPatients with unresectable disease will undergo treatment with proton beam therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
- Staged by PET/CT and esophagogastroduodenoscopy (EGD) OR CT w/contrast and EGD to have stage II or III disease. Endoscopic ultrasound (EUS) is encouraged but not required.
- Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer is eligible, irrespective of margin status.
- Induction chemotherapy prior to concurrent chemoradiation is allowed.
- Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.
Key exclusion criteria (4 listed)
- Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
- Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of study entry.
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 | Radiation | Resectable disease, Unresectable disease |
Primary outcome
Progression-free survival
Time frame: 5 years
Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer. PFS will be assessed using the Kaplan-Meier estimate.
Overall survival
Time frame: 5 years
Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer. OS will be assessed using the Kaplan-Meier estimate.
Progression-free survival
Time frame: 2 years
Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer. PFS will be assessed using the Kaplan-Meier estimate.
Overall survival
Time frame: 2 years
Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer. OS will be assessed using the Kaplan-Meier estimate.
3 secondary outcomes
Patient-reported outcomes of PBT for esophageal cancer at 12 months following chemoradiation.
Time frame: 1 year
Quality of life
Time frame: 6 months
Toxicity
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of insurance coverage for proton beam treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Jeffrey Bradley, M.D. principal investigator
Washington University School of Medicine
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 Proton beam therapy in people with Esophageal Squamous Cell Carcinoma and Adenocarcinoma Of Esophagus, run by Washington University School of Medicine 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 17 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: stopped early, as of the sponsor's last update on 7 Apr 2015. 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 was stopped early (reason given: Lack of insurance coverage for proton beam treatment). 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?
Progression-free survival (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015.