BridgeMD
Compares treatment options for Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Official title Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
ClinicalTrials.gov ID: NCT03801876
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage i esophageal adenocarcinoma ajcc v8.
Also referred to as Ro 09-1978/000, Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- PRIOR TO STEP 1 REGISTRATION:
- Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)
- Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
- History/physical examination
- Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without contrast (preferred) or...
You likely can't join if
- Cervical esophageal cancers arisen from 15-18 cm from the incisors
- Patients with T4b disease according to the AJCC 8th edition
- Definitive clinical or radiologic evidence of metastatic disease
- Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment
- Prior thoracic radiotherapy that would result in overlap of radiation therapy fields
- Severe, active co-morbidity defined as follows:
See the full eligibility criteria
- PRIOR TO STEP 1 REGISTRATION:
- Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)
- Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
- History/physical examination
- Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast
- For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration
- For patients who DID receive induction chemotherapy, scan must occur:
- Within 30 days after final induction chemotherapy dose; OR
- Within 30 days prior to Step 1 registration
- Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible
- Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation
- Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration; only FOLFOX, CAPOX...
- Age ≥ 18
- Zubrod performance status 0, 1, or 2
- Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration)
- For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm\^3
- For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm\^3
- Platelets (within 30 days prior to Step 1 registration)
- For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL
- For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable) (within 30 days prior to Step 1 registration)
- Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance \> 40 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration)
- Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- Cervical esophageal cancers arisen from 15-18 cm from the incisors
- Patients with T4b disease according to the AJCC 8th edition
- Definitive clinical or radiologic evidence of metastatic disease
- Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment
- Prior thoracic radiotherapy that would result in overlap of radiation therapy fields
- Severe, active co-morbidity defined as follows:
- Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration
- Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration
- Myocardial infarction within 3 months prior to Step 1 registration
- Pregnant and/or nursing females
- Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy...
- PRIOR TO STEP 2 REGISTRATION:
- Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Alton, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- Shiloh, Illinois, United States
- Warrenville, Illinois, United States
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Boston, Massachusetts, United States
- Bay City, Michigan, United States
- Dearborn, Michigan, United States
+ 60 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; Coral Gables, Florida, United States; Deerfield Beach, Florida, United States; Doral, Florida, United States and 74 more location(s). 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.