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

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

Detailed Description
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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

Official Title
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Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Radiation: 18F-FDG (Fluorodeoxyglucose) PET
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer<br>Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel. | Radiation: 18F-FDG (Fluorodeoxyglucose) PET<br> <br> Drug: Carboplatin<br> <br> Drug: Paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Neoadjuvant, Proton Beam Radiotherapy