New proton combo aims to improve esophageal cancer treatment
NCT ID NCT01684904
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing a combination of proton radiation and chemotherapy (carboplatin and paclitaxel) before surgery for patients with resectable esophageal or esophagogastric junction cancer. The goal is to see if this approach is safe, tolerable, and effective at improving overall survival. The study enrolls 38 participants with specific stages of the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton radiation combined with carboplatin and paclitaxel chemotherapy
- What this could lead to
- If successful, this could offer a more effective and less toxic treatment option for esophageal cancer patients, potentially improving survival rates.
- What could go wrong
- This is a small, early-phase trial with only 38 participants, so results may not apply to everyone. The treatment still carries risks of side effects from both chemotherapy and radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2013
- Expected to finish
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Aug 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Loma Linda University Medical Center
RECRUITINGLoma Linda, California, 92354, United States
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