No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
Loma Linda University · Other
Who this trial is looking for
This trial is looking for adults with specific types of esophagus cancer. If you join, you will receive a combination of chemotherapy and proton therapy, followed by surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with esophagus cancer
I am at least 18 years old
I have a good performance status
I have undergone specific tests to check my cancer stage
I can have surgery after treatment
I have normal kidney and liver function
I am not pregnant or nursing
I can use effective contraception if I am sexually active
You may not be able to join if
I have cervical esophageal cancer
I have not been cancer-free from a prior invasive cancer for at least 2 years
I have had radiation therapy for esophageal cancer before
I have evidence of a tracheoesophageal fistula
I am unable to have surgery due to medical reasons
I have an allergy to paclitaxel or carboplatin
I have severe health problems that could affect my survival
I have T1N0 disease or T4 disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 inve…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 Committe…
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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Contacts
Proton Referral Office First call: Referral Office intake personnel
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