Carboplatin/Paclitaxel with Proton Chemotherapy for Resectable Esophageal or Esophagogastric Junction Cancer
This study aims to assess the overall survival of patients treated with proton-chemotherapy followed by surgery, who have resectable primary esophageal or esophagogastric cancer.
Proton radiation
Digestive System Diseases+6
+ Digestive System Neoplasms
+ Esophageal Diseases
Treatment Study
Summary
Study start date: February 20, 2013
Actual date on which the first participant was enrolled.This study focuses on treating esophageal or esophagogastric junction cancer that can be removed by surgery. The main goal is to evaluate the safety, side effects, and effectiveness of a treatment plan that combines a proven chemotherapy regimen (carboplatin and paclitaxel) with proton therapy, followed by surgery. The study aims to improve upon the standard treatment by adding paclitaxel, a drug that fights advanced esophageal cancer and enhances radiation effectiveness, and by replacing cisplatin with carboplatin, which is less toxic and easier to administer. This research is important because it could offer significant benefits for patients, potentially improving survival rates and reducing treatment-related side effects. During the study, participants will receive the chemotherapy drugs carboplatin and paclitaxel, along with proton therapy. This treatment will be followed by surgery to remove the cancer. The study's primary outcome is to measure the overall survival of patients receiving this treatment plan. This will help determine if the new approach is more effective than the current standard of care. The study also considers potential benefits and risks associated with this treatment approach.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Loma Linda University Medical Center
Loma Linda, United StatesOpen Loma Linda University Medical Center in Google Maps