Esophageal Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT02213497

Recruitment Status:

Active, not recruiting

Sponsor:

Abramson Cancer Center of the University of Pennsylvania

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There is 1 Location for this study

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Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT02213497

Recruitment Status:

Active, not recruiting

Sponsor:


Abramson Cancer Center of the University of Pennsylvania

How clear is this clinincal trial information?

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