What this study is
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.
What's being tested
- Capecitabine
Intervention · DRUG
- Chemotherapy
Intervention · DRUG
Receive induction chemotherapy
- Conventional Surgery
Intervention · PROCEDURE
Undergo surgery
- Fluorouracil
Intervention · DRUG
- Radiation Therapy
Intervention · RADIATION
Undergo RT
Both Capecitabine and Fluorouracil
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Study details
- Official title
- A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Gastric Adenocarcinoma · Oligometastasis · Stage IV Esophageal Adenocarcinoma AJCC v7 · Stage IV Esophageal Cancer AJCC v7 · Stage IV Gastric Cancer AJCC v7
- Enrolling
- 100 people
- Starts
- 2018-02-19
- Est. completion
- 2026-12-31
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 79 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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 cancerExcept: 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.
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- Quynh-Nhu Nguyen · Contact713-563-2300
- Quynh-Nhu Nguyen · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2016-0972
Principal investigator
Quynh-Nhu Nguyen
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.