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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Fluorodeoxyglucose F18; Paclitaxel

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 ( 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