Proton Therapy for Esophageal Cancer (NCT01684904) | Clinical Trial Compass
RecruitingNot Applicable
Proton Therapy for Esophageal Cancer
United States38 participantsStarted 2013-02-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer
Timeframe: 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
Trial details
NCT IDNCT01684904
SponsorLoma Linda University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-08
Contact for this trial
Proton Referral Office First call: Referral Office intake personnel