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

NCT02213497 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: UPCC 01214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Neoadjuvant; Proton Beam Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  3 years

Study Arms (1)

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.

Radiation: 18F-FDG (Fluorodeoxyglucose) PET; Drug: Carboplatin; Drug: Paclitaxel

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Fluorodeoxyglucose F18; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• John Plastaras, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 11, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)