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

Primary Purpose

Esophageal Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-FDG (Fluorodeoxyglucose) PET
Carboplatin
Paclitaxel
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring Esophageal Cancer, Neoadjuvant, Proton Beam Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
August 4, 2014
Last Updated
December 15, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02213497
Brief Title
Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Official Title
Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, Neoadjuvant, Proton Beam Radiotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
Arm Type
Experimental
Arm Description
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
Intervention Type
Radiation
Intervention Name(s)
18F-FDG (Fluorodeoxyglucose) PET
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Plastaras, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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