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About
Background:
The number of patients with esophageal cancer keeps rising. For many patients, a combination of surgery, chemotherapy, and radiation is necessary to completely treat the disease. Usually, patients receive chemotherapy and radiation at the same time followed by surgery to remove the part of the esophagus with the tumor (Neoadjuvant chemoradiotherapy (nCRT)). Researchers want to learn how to make this treatment more effective.
Objective:
To see if biopsies before treatment can show which patients will do the best with a combination of chemotherapy, radiation, and surgery.
Eligibility:
Adults at least 18 years old with esophageal adenocarcinoma or squamous cell carcinoma who should be treated with chemotherapy, radiation, and surgery.
Design:
Patients will undergo standard testing that is routine for all patients with this disease. These tests include:
Medical history
Physical exam with activity and nutritional assessment
Standard lab tests
Imaging studies including a computerized axial tomography (CAT) scan and positron-emission tomography (PET) scan
Breathing test into a machine to measure size and function of lungs.
Biopsy for a small sample of tumor is removed by esophagogastroduodenoscopy (EGD): A tube inserted into the mouth under anesthesia
Endoscopic ultrasound is performed in some but not all patients.
Patients will have nCRT at the clinic or with their local doctor.
In 6 -12 weeks after nCRT, patients will undergo surgery with:
After surgery, patients are usually in the hospital for 2 weeks and have a feeding tube for at least 2 weeks and potentially longer until they are eating enough to not lose weight.
Patients will return for follow-up visits with labs and CAT scans every 6 months for the first two years then every year afterwards.
Full description
Background:
Radiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) trial.
Primary Objective:
-To determine whether a metabolomic signature in tumor, blood, or urine or whether BH3 profiling of pre-neoadjuvant tumor biopsies correlates with the outcome of pathological complete response after neoadjuvant chemoradiotherapy for patients with esophageal adenocarcinoma or squamous cell carcinoma.
Eligibility:
-Patients with locally-advanced, histologically confirmed EAC or ESCC who are candidates for nCRT and esophagectomy.
Design:
Blood, urine, normal esophagus, and tumor (if present) will be obtained after neoadjuvant therapy.
Enrollment
Sex
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Inclusion and exclusion criteria
leukocytes greater than or equal to 3,000/mcL
absolute neutrophil count greater than or equal to 1,500/mcL
platelets greater than or equal to 50,000/mcL
EXCLUSION CRITERIA:
Patients in which nCRT followed by surgery is not the appropriate management:
Patients in which biopsy prior to starting nCRT is not obtainable.
Patients who previously received neoadjuvant chemotherapy
Concomitant medical problems in the opinion of physician that would place the patient at unacceptable risk for a major surgical procedure.
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, heart failure, hepatic disease that prohibits administration of neoadjuvant therapy or surgery.
Women who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
Patients with a diagnosis of another malignancy that is either active or in remission less than five years. Basal cell and squamous cell carcinoma of the skin are not contraindications to this protocol
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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