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

Abramson Cancer Center at Penn Medicine

Status and phase

Active, not recruiting

Phase 1

Conditions

Esophageal Cancer

Treatments

Radiation: 18F-FDG (Fluorodeoxyglucose) PET

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Identifiers

UPCC 01214

Details and patient eligibility

About

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

Full description

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.
To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.
To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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