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Clinical Trials/NCT02213497
NCT02213497Active, not recruitingPhase 1

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

Abramson Cancer Center at Penn Medicine2 sites in 1 country30 target enrollmentStarted: April 1, 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
30
Locations
2
Primary Endpoint
Number of Adverse Events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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 mm
  • •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

Arms & Interventions

Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer

Experimental

Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.

Intervention: 18F-FDG (Fluorodeoxyglucose) PET (Radiation)

Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer

Experimental

Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.

Intervention: Carboplatin (Drug)

Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer

Experimental

Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.

Intervention: Paclitaxel (Drug)

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: 3 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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