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

Phase 1

Active, not recruiting

• Conditions: Esophageal Cancer
• Interventions: Radiation: 18F-FDG (Fluorodeoxyglucose) PET; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT02213497
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer	18F-FDG (Fluorodeoxyglucose) PET	Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer	Carboplatin	Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer	Paclitaxel	Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	3 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States