Proton therapy for treating esophageal cancer
A Phase II Trial of Proton Chemotherapy (PCT) for Resectable Esophageal or Esophagogastric Junction Cancer
This study tests a new treatment for localized esophageal cancer that combines proton therapy with chemotherapy to see if it can work better and cause less harm than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT01684904 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility, toxicity, and efficacy of a treatment regimen that combines proton therapy with a systemic chemotherapy regimen of carboplatin and paclitaxel, followed by definitive surgery. The aim is to improve upon traditional chemotherapy regimens by using carboplatin to reduce toxicity and adding paclitaxel, which enhances the effectiveness of radiation. The study focuses on patients with localized esophageal cancer, specifically targeting those with squamous cell or adenocarcinoma types. The treatment approach is designed to optimize dose distribution patterns using proton beam therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed squamous cell or adenocarcinoma of the esophagus at specific stages and locations.
Not a fit: Patients with tumors located at the carina or above, or those with significant comorbidities affecting treatment tolerance, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less toxic option for patients with esophageal cancer.
How similar studies have performed: Other studies have shown promise with proton therapy in cancer treatment, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 \-
Where this trial is running
Loma Linda, California
- Loma Linda University Medical Center — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Gary Yang, MD — gyang@llu.edu
- Study coordinator: Proton Referral Office First call: Referral Office intake personnel
- Phone: 909-558-4288 or 1 800 PROTONS
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.