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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/17/2018
Start Date:April 2014
Contact:John Plastaras, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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

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


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: John Plastaras, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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