Proton Therapy for Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Aug 26, 2028
  • participants needed
    38
  • sponsor
    Loma Linda University
Updated on 26 February 2021
paclitaxel
cancer
endoscopy
serum pregnancy test
fluorouracil
endoscopic ultrasound
x-rays
neutrophil count
carboplatin
esophageal cancer
adenocarcinoma
blood urea nitrogen
celiac disease
esophagus cancer
adenocarcinoma of esophagus

Summary

The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.

In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.

Details
Condition Esophageal Cancer, esophagus cancer, oesophageal cancer
Treatment Proton Radiation
Clinical Study IdentifierNCT01684904
SponsorLoma Linda University
Last Modified on26 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Esophageal Cancer?
Do you have any of these conditions: oesophageal cancer or esophagus cancer or Esophageal Cancer?
Do you have any of these conditions: Esophageal Cancer or esophagus cancer or oesophageal cancer?
Do you have any of these conditions: esophagus cancer or oesophageal cancer or Esophageal Cancer?
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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