A Phase II Trial of Proton Chemotherapy (PCT) for Resectable Esophageal or Esophagogastric Junction Cancer
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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