NCT02213497

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	18F-FDG (Fluorodeoxyglucose) PET
DRUG	Carboplatin
DRUG	Paclitaxel

Timeline

• Start date: 2014-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2014-08-11
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States