CLINICAL TRIAL

Radiation Therapy for Adenocarcinoma

Metastatic
Waitlist Available · 18+ · All Sexes · Butte, MT

This study is evaluating whether radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer.

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma · Esophageal Neoplasms · Adenocarcinomas of the Gastroesophageal Junction · Stage IIIA Esophageal Cancer AJCC v7 · Stage IIA Esophageal Cancer AJCC v7 · Stage IIB Esophageal Cancer AJCC v7 · Stage IIIB Esophageal Cancer AJCC v7 · Esophageal Adenocarcinoma (EAC) · Stage IB Esophageal Cancer AJCC v7

Treatment Groups

This trial involves 2 different treatments. Radiation Therapy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Trastuzumab
BIOLOGICAL
+
Quality-of-Life Assessment
OTHER
+
Laboratory Biomarker Analysis
OTHER
+
Therapeutic Conventional Surgery
PROCEDURE
+
Carboplatin
DRUG
+
Radiation Therapy
RADIATION
+
Paclitaxel
DRUG
Experimental Group 2
Quality-of-Life Assessment
OTHER
+
Laboratory Biomarker Analysis
OTHER
+
Therapeutic Conventional Surgery
PROCEDURE
+
Carboplatin
DRUG
+
Radiation Therapy
RADIATION
+
Paclitaxel
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Therapeutic Conventional Surgery
2014
Completed Phase 3
~8360
Carboplatin
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Paclitaxel
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
Platelets >= 100,000 cells/mm^3
Pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction; the cancer may involve the stomach up to 5 cm
Endoscopy with biopsy
PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION
Intent to submit tissue for central HER2 testing
Chest/abdominal/pelvic computed tomography (CT) or whole-body positron emission tomography (PET)/CT (NOTE: if CT is performed at this time point, whole-body PET/CT will be required prior to step 2 registration; PET/CT of skull base to mid-thigh is acceptable) (NOTE: if adenopathy is noted on CT or whole-body PET/CT scan, an endoscopic ultrasound is not required prior to STEP 2 registration as long as adequate tissue has been obtained for central HER2 testing)
Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be =< 2 cm
Zubrod performance status 0-2
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 6 weeks after end of radiation, 1 and 2 years from treatment start
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 6 weeks after end of radiation, 1 and 2 years from treatment start
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 6 weeks after end of radiation, 1 and 2 years from treatment start.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Radiation Therapy will improve 1 primary outcome and 7 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of At the time of surgery, 5-8 weeks after completion of radiation therapy..

Percentage of Participants With Pathologic Complete Response at Surgery
AT THE TIME OF SURGERY, 5-8 WEEKS AFTER COMPLETION OF RADIATION THERAPY.
Pathologic Complete Response (pCR) is evaluated after surgery and is based on the pathology review of the submitted surgical specimen. Pathologic Complete Response occurs if the pathologist determines that the resected esophageal specimen, accompanying lymph nodes, and surgical margins are all free of tumor.
AT THE TIME OF SURGERY, 5-8 WEEKS AFTER COMPLETION OF RADIATION THERAPY.
Quality-adjusted Survival
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF PRIMARY OUTCOME MEASURE ANALYSIS WAS 8 YEARS.
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF PRIMARY OUTCOME MEASURE ANALYSIS WAS 8 YEARS.
Molecular Correlates of Efficacy
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF PRIMARY OUTCOME MEASURE ANALYSIS WAS 8 YEARS.
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF PRIMARY OUTCOME MEASURE ANALYSIS WAS 8 YEARS.
Number of Participants With Any Cardiac Adverse Events Regardless of Attribution
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF ANALYSIS WAS 8 YEARS.
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF ANALYSIS WAS 8 YEARS.
Overall Survival
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF ANALYSIS WAS 8 YEARS.
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF ANALYSIS WAS 8 YEARS.
Frequency of Highest Grade Adverse Event Per Participant
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF ANALYSIS WAS 8 YEARS.
Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.
FROM RANDOMIZATION TO LAST FOLLOW-UP. MAXIMUM FOLLOW-UP AT TIME OF ANALYSIS WAS 8 YEARS.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of adenocarcinoma?

The most discriminating signs of an adenocarcinoma are the presence of lysis in the lymph vessels, hemorrhaging outside the capsule, and enlargement of the lymph node capsule in the neck.

Anonymous Patient Answer

How many people get adenocarcinoma a year in the United States?

The incidence of adenocarcinoma is increasing in all racial, age, and sex categories. The incidence of adenocarcinoma in the entire population rose from 37.2 per 100,000 population in 1990 to 54.7 per 100,000 population in 2000.

Anonymous Patient Answer

What are common treatments for adenocarcinoma?

It is important that providers and patients discuss commonly used treatments and follow-up care in order to reduce unmet care needs. In addition, care can be delivered in a more effective and timely fashion by addressing patient barriers to care, and the patient's care needs are better met if physicians have the most up-to-date knowledge about the disease and protocols for appropriate treatment.

Anonymous Patient Answer

What causes adenocarcinoma?

There are 3 major causes of adenocarcinoma and most arise from digestive or respiratory system. The most common is stomach malignancies and the second most common is uterothread cancers. As for respiratory system malignancies, most occurred in lung cancer.\n

Anonymous Patient Answer

What is adenocarcinoma?

Adenocarcinoma of the oesophagus and gastro-oesophageal junction are two of the more common forms of oesophageal cancer. A careful examination of the upper GI tract during endoscopic or surgical procedures is essential to facilitate the appropriate diagnosis and to guide treatment.\n

Anonymous Patient Answer

Can adenocarcinoma be cured?

Adenocarcinoma can be cured by an adjuvant therapy, such as chemotherapy, which was introduced into the treatment of lung adenocarcinomas less than 35 years ago.

Anonymous Patient Answer

How quickly does adenocarcinoma spread?

Adenocarcinoma is a fast-growing aggressive cancer that usually spreads very quickly into and beyond the larynx, and it can invade the neck and the lungs. Adenocarcinoma of the larynx is the most common site for local and regional disease spread. Even if it escapes the head and neck region, adenocarcinoma can cause massive distant spread by periductal and perineural invasion to the distant lymph nodes or lungs.

Anonymous Patient Answer

What is radiation therapy?

Radiation therapy has been used for many years and it has been associated with fewer side effects and more positive clinical outcomes. It could be used as an alternative in patients with locally advanced non-operable carcinoma, in the patients with limited disease, in the patients with a known N2 disease and in the patients who are not candidates for surgery, and radiation remains the standard of care. Furthermore, the majority of patients in our series did not require subsequent surgery, and a number of patients have been followed up to more than five years after the end of treatment. It is important to remember that, even though local control rates have increased, overall survival remains low. Nevertheless, the authors of this series urge more effort into optimizing radiation dosage protocols.

Anonymous Patient Answer

What is the primary cause of adenocarcinoma?

Adenocarcinoma may represent either a neoplastic process or an exogenous cause. The cause of adenocarcinoma by tumor type should be considered when evaluating the pathogenesis of adenocarcinoma.

Anonymous Patient Answer

What are the common side effects of radiation therapy?

Radiation induced dermatitis occurred with a relatively high frequency (>30%), and was associated with the duration of exposure in most patients. Some physicians may feel they can control dermatitis by changing the radiation schedule or delivery technique. However, the treatment should be adjusted based on the skin toxicity that develops.

Anonymous Patient Answer

How does radiation therapy work?

In both [small cell lung cancer](https://www.withpower.com/clinical-trials/small-cell-lung-cancer) and non-small cell lung cancer, radiation therapy was found to be an effective treatment. To find out when it is optimal to give radiation therapy to a person, one must assess the risks and benefits of radiation therapy to the patient.

Anonymous Patient Answer

Is radiation therapy typically used in combination with any other treatments?

Overall, the results of this research indicate that combination therapies should be the procedure of choice in the treatment of T4 breast cancer to decrease the risk of local recurrence and to improve the quality of life of patients.

Anonymous Patient Answer
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