Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Blood DNA will be isolated from plasma. Tumor DNA will be purified with a kit and amplified regions of 10 genes discovered to by mutated in whole exome sequencing.

Blood and Tissue Collection

Shanda Blackmon, MD, MPH

To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

Esophageal carcinoma is an aggressive malignancy and about a third of patients present with distant metastatic disease. While survival is slowly improving with better diagnostic tools and therapy, the overall 5-year survival remains low at 18%. Unlike other malignancies, such as colon cancer and prostate cancer, there is no peripheral blood marker of response or recurrence during treatment in esophageal cancer. However, quantifying cfDNA is a unique and tumor specific avenue that may allow real time response to treatment in esophageal cancer.

To identify esophageal cancer specific mutations, tumor samples will undergo whole exome sequencing. From this data, the investigators will select 10-15 genes to focus their efforts. PCR primers will be designed to detect these tumor specific mutations in the cell-free component of peripheral blood samples over the course of treatment for esophageal cancer.

The investigators will obtain baseline blood (before treatment) and then collect blood after neoadjuvant treatment, after surgery, and then at subsequent visits from the participants.

Patients will have blood drawn prior to any neoadjuvant treatment or surgery. Tumor tissue will be collected and stored after pathologic evaluation has been completed. Blood collections will then be drawn at every subsequent follow up visit at Mayo Clinic for surveillance.

Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence

To identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

To validate cfDNA as a marker of recurrence of esophageal cancer.

Mayo Clinic

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Digestive System Abnormalities

Patients who have undergone esophagectomy, esophageal reconstruction, or treatment

Patients who have an upper digestive disease.

Mayo Clinic patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.

Mayo Clinic Upper Digestive Disease Survey on Paper

Mayo Clinic and non Mayo Clinic patients can participate by loading the app through the app store. Patient consent will be completed in the app. Patients will be asked to complete questionnaires at their 1.5 month surgical or diagnosis follow up and then every three months for 1 year after their surgery or diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime or as long as they want to participate.

for iOS: https://apps.apple.com/us/app/upper-digestive-disease/id6448756724 for Android: https://play.google.com/store/apps/details?id=com.mayoclinic.uddmobile\&pli=1

Upper Digestive Disease (UDD Monitor) App

Mohamad Khair Abou Chaar, MD

Karlyn Pierson, MAN, RN

Luis Tapias Vargas, MD

The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.

The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes.

Patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.

Mayo Clinic Upper Digestive Disease Survey

Completed Mayo Clinic Upper Digestive Disease Survey will be analyzed and used to establish validation.

Completed Mayo Clinic Upper Digestive Disease Survey will be used in the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure at different time points following surgery.

Principal Investigator

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Patients with baseline PET scan assigned to this Arm will receive two cycles of 3-weekly schedule of induction chemotherapy with paclitaxel/cisplatin (TP), consisting of paclitaxel 150 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\<35% decrease in SUVmax) crossed over to FOLFOX regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions.

Patients with baseline PET scan assigned to this Arm will receive three cycles of 2-weekly schedule of induction chemotherapy with FOLFOX (oxaliplatin, leucovorin, 5-FU), consisting of oxaliplatin 85 mg/m2 on day 1, leucovorin 400 mg/m2, and 5-FU 2 g/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\<35% decrease in SUVmax) crossed over to TP regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions.

5-FU

Intensity-modulated radiotherapy

Using PET to evaluate response to induction chemotherapy

Mian XI, MD

Mengzhong Liu, MD

Mian Xi, MD

Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. The aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on PET response to induction chemotherapy can improve clinical complete response (cCR) in patients with unresectable esophageal squamous cell carcinoma (ESCC).

A total of 216 patients with baseline PET scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (TP) on days 1, 22 or FOLFOX (oxaliplatin, leucovorin, 5-FU) on days 1, 15, 29. Repeat PET was performed on days 36-42 and changes in max standardized uptake value (SUVmax) from baseline were assessed. Using a predefined cut-off value of a 35% decrease in SUVmax, PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\<35% decrease in SUVmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions, 5 days per week.

PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

A Phase II Randomized Trial of PET Imaging in Assessing Response to Induction Chemotherapy in Esophageal Squamous Cell Carcinoma Treated With Definitive Chemoradiotherapy

RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies.

From the enrollment to the date of death from any cause or date of lost follow-up

From the date of randomization to the date of disease progression or last follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence	NCT03108885	Esophageal Neop... Esophageal Neop... Esophageal Neop... Cancer of Esoph... Cancer of the E... Esophageal Canc... Esophagus Cance... Neoplasm, Esoph...	Blood and Tissu...	19 Years -	Mayo Clinic
Mayo Clinic Upper Digestive Disease Survey	NCT02530983	Esophageal Neop... Cancer of Esoph... Cancer of the E... Esophageal Canc... Esophagus Cance... Neoplasm, Esoph... Esophagectomy Abnormalities, ... Digestive Syste...	Mayo Clinic Upp... Upper Digestive...	18 Years -	Mayo Clinic
PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma	NCT03791905	Neoplasm, Esoph... Squamous Cell C...	Paclitaxel Cisplatin Oxaliplatin 5-FU Leucovorin Intensity-modul... PET	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for neoplasm, esophageal