Esophageal Cancer
Conditions
Keywords
Esophageal Cancer, Neoadjuvant, Proton Beam Radiotherapy
Brief summary
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
Detailed description
1. 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. 2. To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy. 3. To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy
Interventions
RADIATION18F-FDG (Fluorodeoxyglucose) PET
DRUGCarboplatin
DRUGPaclitaxel
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | 3 years |
Countries
United States
Outcome results
None listed