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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02213497
• Other study ID #: UPCC 01214
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• 18F-FDG (Fluorodeoxyglucose) PET

Drug:
• Carboplatin

• Paclitaxel

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		3 years