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New treatment option for Esophagus Cancer
Official title Proton Therapy for Esophageal Cancer
ClinicalTrials.gov ID: NCT01684904
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus that involves the mid, distal or esophagogastric junction. The...
- 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...
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cell/mm3
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.