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

18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

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

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

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

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


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer

Outcome Time Frame:

The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Safety Issue:


Principal Investigator

Gary Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

August 2016

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Loma Linda University Medical CenterLoma Linda, California  92354