Proton Therapy for Esophageal Cancer

NCT01684904 | Recruiting DMC FDA Device

• 1 other identifier: 5120054
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil. In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

• To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer

  The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Study Arms (1)

Proton radiation

EXPERIMENTAL

Proton radiation

Radiation: Proton radiation

Interventions

Proton radiation RADIATION

Proton radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus that involves the mid, distal or esophagogastric junction. The cancer may involve the stomach up to 5 cm.
• Endoscopy with biopsy
• Stage T1N102, T2-3N0-2 according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based upon the following minimum diagnostic work-up:
• History/physical examination with documentation of patient's weight within 30 days of registration
• Chest/Abdominal/Pelvic contrast CT within 56 days of registration
• Whole body PET/CT within 56 days of registration
• Endoscopic ultrasound
• Patients may have regional adenopathy including para-esophageal, gastric, gastroheptaic and celiac nodes. If celiac adenopathy present, it must be ≤ 2cm.
• Patients with tumors at the level of the carina or above should undergo bronchoscopy to exclude fistula
• Pulmonary function test (including routine spirometry and DLCO) within 60 days prior to registration
• Serum creatinine ≤ 2 x the upper limit of normal within 4 weeks of registration
• Na, K, BUN, Glucose within 4 weeks prior to registration
• CBC/differential within 4 weeks prior to registration with adequate bone marrow function, defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cell/mm3

You may not qualify if:

• Patients with cervical esophageal carcinoma
• Patients with T1N0 disease and T4 disease
• Prior radiation for esophageal cancer or prior chest radiotherapy
• Prior chemotherapy for esophageal cancer
• Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
• Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years ( e.g. carcinoma in situ of breast, oral cavity, or cervix are permissible)
• Prior radiotherapy that would results in overlap of radiation fields
• Medical contraindications to esophagectomy
• Prior allergic reaction to paclitaxel or carboplatin
• Severe, active co-morbidity that may impact survival
• Pregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Gary Yang, MD

  gyang@llu.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Proton Referral Office First call: Referral Office intake personnel

CONTACT

909-558-4288 or 1 800 PROTONS

Gary Yang, MD

CONTACT

909-558-4000; gyang@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 13, 2012
• Study Start: February 20, 2013
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2032
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)