Status:
ACTIVE_NOT_RECRUITING
Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 es...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02213497
Start Date
April 1 2014
End Date
December 31 2026
Last Update
January 8 2026
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104