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NCT02213497Active, not recruitingPhase 1

Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer

Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
4 Aug 2014
Start date
Apr 2014
Primary completion date
31 Dec 2026
Lead sponsor
Abramson Cancer Center at Penn Medicine
NCT number
NCT02213497

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From Apr 2014 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)

Other

  • 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
  • Pregnant women, women planning to become pregnant and women that are nursing

Who the study is looking for

  • 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
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Abramson Cancer Center of the University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.