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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02213497
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 105
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Radiation: 18F-FDG (Fluorodeoxyglucose) PET; Drug: Carboplatin; Drug: Paclitaxel	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
• Study Start Date: Apr 1, 2014
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Number of Adverse Events [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: John Plastaras, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02213497
• Other Study ID Numbers: UPCC 01214
• First Posted: Aug 11, 2014
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
• Additional relevant MeSH terms: Esophageal Neoplasms; Paclitaxel; Carboplatin; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Sep 28, 2021