Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Diagnostic
Intervention
Name: 18F-FDG (Fluorodeoxyglucose) PET Type: Radiation
Name: Carboplatin Type: Drug
Name: Paclitaxel Type: Drug
Overall Status
Recruiting
Summary
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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

- 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
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: John Plastaras, MD - 855-216-0098 - PennCancerTrials@emergingmed.com
Start Date
April 2014
Completion Date
April 2017
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page