Esophageal CancerPhase 1NCT02213497
Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
A Phase 1 study testing 18F-FDG (Fluorodeoxyglucose) PET, Carboplatin and Paclitaxel in people with Esophageal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel. 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?
- 18F-FDG (Fluorodeoxyglucose) PET, Carboplatin and Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 31 Dec 2026
- Phase
- Phase 1
- 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
- Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
- Patients with AJCC 7th edition clinical stage IIB-IIIC
- Patient must be >18 years of age.
- Patients must have an ECOG Performance Status of 0-1
- Patients must be able to provide informed consent.
- Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function
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- serum AST and ALT < 2 times the upper limit of normal
- Patients must have bilirubin < 1.5 × normal.
- WBC > 3000/mm3, platelets > 100,000 mm3.
- Hemoglobin > 10 g/dL serum creatinine < 1.5 times the upper limit of normal
- Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
Who cannot join
- Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
- Patients with primary tumors located at or above the carina
- Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- Pregnant women, women planning to become pregnant and women that are nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
Read the detailed description
- To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for esophageal cancer.
- To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.
- To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy
- Conditions
- Esophageal Cancer
- Being tested
- 18F-FDG (Fluorodeoxyglucose) PET, Carboplatin, Paclitaxel
- Keywords
- Esophageal Cancer, Neoadjuvant, Proton Beam Radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG (Fluorodeoxyglucose) PETRadiation
CarboplatinDrug
PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer | Experimental | Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel. Receives: Radiation: 18F-FDG (Fluorodeoxyglucose) PET; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Plastaras, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213497
- Sponsor's protocol ID
- UPCC 01214
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2014
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02213497
- Acronym / sponsor ID
- UPCC 01214
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Neoadjuvant, Proton Beam Radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Aug 2014 (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.
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
Detailed description
- To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for esophageal cancer.
- To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.
- To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer | Experimental | Radiation: 18F-FDG (Fluorodeoxyglucose) PET, Drug: Carboplatin, Drug: PaclitaxelPatients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
- Patients with AJCC 7th edition clinical stage IIB-IIIC
- Patient must be >18 years of age.
- Patients must have an ECOG Performance Status of 0-1
- Patients must be able to provide informed consent.
Key exclusion criteria (4 listed)
- Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
- Patients with primary tumors located at or above the carina
- Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
- Pregnant women, women planning to become pregnant and women that are nursing
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 |
|---|---|---|
| 18F-FDG (Fluorodeoxyglucose) PET | Radiation | Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer |
| Carboplatin | Drug | Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer |
| Paclitaxel | Drug | Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer |
Primary outcome
Number of Adverse Events
Time frame: 3 years
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 8 Jan 2026.
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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.
John Plastaras, MD principal investigator
Abramson Cancer Center at Penn 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 18F-FDG (Fluorodeoxyglucose) PET, Carboplatin and Paclitaxel in people with Esophageal Cancer, run by Abramson Cancer Center at Penn 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 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 8 Jan 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 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?
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?
Number of Adverse Events (time frame: 3 years). 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 8 Jan 2026.