Proton Therapy for Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT01684904 |
Recruitment Status :
Recruiting
First Posted : September 13, 2012
Last Update Posted : March 4, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophagus Cancer | Radiation: Proton radiation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Proton Chemotherapy (PCT) for Resectable Esophageal or Esophagogastric Junction Cancer |
Actual Study Start Date : | February 20, 2013 |
Estimated Primary Completion Date : | August 2027 |
Estimated Study Completion Date : | August 2032 |

Arm | Intervention/treatment |
---|---|
Experimental: Proton radiation
Proton radiation
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Radiation: Proton radiation |
- To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer [ Time Frame: 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 ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)
Adequate liver function, defined as total bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x the upper limit of normal within 4 weeks of registration
Age ≥ 18
Zubrod performance status 0-2 within 4 weeks of registration
Surgical consultation to confirm that patient will be able to undergo curative resection after completion of PCT prior to registration
For women of childbearing potential, a negative serum pregnancy test within 14 days prior to registration
Women of childbearing potential and male participants must practice adequate contraception while on study
Patient must sign study specific informed consent prior to study entry
Exclusion Criteria:
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684904
Contact: Sandi Teichman or Miriam Hernandez Study Coordinators, RN | 909-558-4000 ext 55240 / 88231 | scteichm@llu.edu; mvhernandez@llu.edu | |
Contact: Gary Yang, MD | 909-558-4000 ext 15689 | gyang@llu.edu |
United States, California | |
Loma Linda University Medical Center | Recruiting |
Loma Linda, California, United States, 92354 | |
Contact: Gary Yang, MD 909-558-4280 gyang@llu.edu | |
Principal Investigator: Gary Yang, MD |
Principal Investigator: | Gary Yang, MD | gyang@llu.edu |
Responsible Party: | Gary Yang, MD, MD, Principal Investigator, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT01684904 |
Other Study ID Numbers: |
5120054 |
First Posted: | September 13, 2012 Key Record Dates |
Last Update Posted: | March 4, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |