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

NCT ID: NCT02213497

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed Description

1. 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.

2. To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.

3. To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer

Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.

Group Type: EXPERIMENTAL

18F-FDG (Fluorodeoxyglucose) PET

Intervention Type: RADIATION

Carboplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Interventions

18F-FDG (Fluorodeoxyglucose) PET

Intervention Type: RADIATION

Carboplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Plastaras, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 01214

Identifier Type: -

Identifier Source: org_study_id