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Trial record 1 of 3 for:    proton esophageal loma linda
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Proton Therapy for Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01684904
Recruitment Status : Recruiting
First Posted : September 13, 2012
Last Update Posted : March 4, 2022
Information provided by (Responsible Party):
Gary Yang, MD, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Radiation: Proton radiation Not Applicable

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Proton radiation
Proton radiation
Radiation: Proton radiation

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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


Information from the National Library of Medicine

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

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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

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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         
Sponsors and Collaborators
Loma Linda University
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Principal Investigator: Gary Yang, MD gyang@llu.edu
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases