RECRUITING

Chemotherapy with or Without Radiation or Surgery in Treating Participants with Oligometastatic Esophageal or Gastric Cancer

Conditions

Gastric Adenocarcinoma Oligometastasis Stage IV Esophageal Adenocarcinoma AJCC V7 Stage IV Esophageal Cancer AJCC V7 Stage IV Gastric Cancer AJCC V7

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Surgery, such as complete surgical resection, may stop the spread of tumor cells by surgically removing organs or tumors. Giving chemotherapy with radiation or surgery may work better than chemotherapy alone in treating participants with oligometastatic esophageal or gastric cancer.

Official Title

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients with Esophageal or Gastric Cancer with Oligometastases

Quick Facts

Study Start:2018-02-19

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03161522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology * The patient is staged with EGD and PET/CT scan. * The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the primary tumor may not provide reproducible measurements for RECIST and may not be visible on CT or PET/CT at diagnosis or after induction chemotherapy. Accordingly, patients are eligible regardless of the imaging measurements of the primary tumor. Additionally, in patients with non-measurable metastases, patients are eligible if there is pathology confirming metastases from a distant site. However, biopsy of a metastatic site is not required if there are visible metastases on imaging (such as ultrasound, diagnostic CT , EUS, PET/CT). * The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion). * Osseous metastases or visceral metastases will each count as one metastatic site. * Each CNS metastases will count as one metastatic site. * Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation. * Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment. * Patient ECOG of 0-2, with life expectancy of at least 6 months * Patients age \>18 yrs old but \<80 yrs old and signed informed consent * Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents.	* Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized. * Patients with fistula documented radiographically or by EDG/EUS, EBUS. * Patients with life expectancy less than 6 months, ECOG \>3 * Female patients who are pregnant confirmed by bHCG lab test. * Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months. * Patients established to have a tumor with Microsatellite Instability High (MSIH) status. * Nursing females * Patients in poor nutritional state * Patients with: * Severely depressed bone marrow function * Potentially serious infections * Known hypersensitivity to 5-fluorouracil * Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)

Inclusion Criteria

Exclusion Criteria

* The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology
* The patient is staged with EGD and PET/CT scan.
* The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the primary tumor may not provide reproducible measurements for RECIST and may not be visible on CT or PET/CT at diagnosis or after induction chemotherapy. Accordingly, patients are eligible regardless of the imaging measurements of the primary tumor. Additionally, in patients with non-measurable metastases, patients are eligible if there is pathology confirming metastases from a distant site. However, biopsy of a metastatic site is not required if there are visible metastases on imaging (such as ultrasound, diagnostic CT , EUS, PET/CT).
* The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion).
* Osseous metastases or visceral metastases will each count as one metastatic site.
* Each CNS metastases will count as one metastatic site.
* Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation.
* Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment.
* Patient ECOG of 0-2, with life expectancy of at least 6 months
* Patients age \>18 yrs old but \<80 yrs old and signed informed consent
* Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents.

* Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized.
* Patients with fistula documented radiographically or by EDG/EUS, EBUS.
* Patients with life expectancy less than 6 months, ECOG \>3
* Female patients who are pregnant confirmed by bHCG lab test.
* Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months.
* Patients established to have a tumor with Microsatellite Instability High (MSIH) status.
* Nursing females
* Patients in poor nutritional state
* Patients with:
* Severely depressed bone marrow function
* Potentially serious infections
* Known hypersensitivity to 5-fluorouracil
* Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)

Contacts and Locations

Study Contact

Quynh Nhu Nguyen, MD

CONTACT

713-563-2300

qnnguyen@mdanderson.org

Principal Investigator

Quynh-Nhu Nguyen

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Quynh-Nhu Nguyen, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-19

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2018-02-19

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Gastric Adenocarcinoma
Oligometastasis
Stage IV Esophageal Adenocarcinoma AJCC V7
Stage IV Esophageal Cancer AJCC V7
Stage IV Gastric Cancer AJCC V7