Proton Therapy for Esophageal Cancer

Launched by LOMA LINDA UNIVERSITY · Sep 10, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for esophageal cancer, which includes a combination of chemotherapy and proton therapy, followed by surgery. The goal is to see if this new combination is safe, effective, and easier on patients compared to the standard chemotherapy used in the past. The chemotherapy regimen uses carboplatin and paclitaxel instead of the older drugs, which may lead to fewer side effects. Proton therapy is being tested because it can target the cancer more precisely, potentially reducing damage to nearby healthy tissues.

To be eligible for this trial, participants must have a specific type of esophageal cancer and meet several health criteria. They should be at least 18 years old, have confirmed cancer through a biopsy, and be in a condition that allows for surgery after treatment. Additionally, they need to pass various health tests to ensure their bodies can handle the treatment. Participants can expect to receive the new treatment and undergo regular health evaluations throughout the trial. It's also important for potential participants to know that they must agree to use effective contraception during the study if they are able to conceive.

Gender

ALL

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 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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