Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

Esophageal Cancer Clinical Trial

— ES01  

Official title:

A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03234842
• Other study ID #: UFPTI 1605-ES01
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 30, 2017
• Est. completion date: December 11, 2018

Study information

• Verified date: December 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.

Description:

Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).

Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must be at least 18 years at the time of consent.

• Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.

• Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.

Exclusion Criteria:

• Patients with cervical esophageal carcinoma.

• Prior radiotherapy with fields overlapping the current esophageal cancer.

• Patients with cT1a disease.

• Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.

• Patients with distant metastatic disease.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• Proton Beam Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
• Photon Radiation Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

Drug:
• Chemotherapy
Concurrent weekly chemotherapy at standard doses

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of = 10% from baseline) between protons and photons after preoperative or definitive chemoradiation	Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy	Approximately 12 months after radiation therapy
Secondary	Compare quality of life	Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy	Approximately 12 months after radiation therapy
Secondary	Compare outcomes for local control	Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy	Approximately 12 months after radiation therapy
Secondary	Compare outcomes for progression free survival	Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy	Approximately 12 months after radiation therapy
Secondary	Compare overall survival rates	Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy	Approximately 12 months after radiation therapy