Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- To evaluate whether esophageal or gastric patients with oligometastatic cancer without disease progression after first line chemotherapy therapy will demonstrate improved overall survival (OS) with early local therapy (concurrent chemotherapy/radiation and surgery).
SECONDARY OBJECTIVES:
-
Assess the relationships between progression-free survival and overall survival between both treatment arms.
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Report local control, loco-regional control. III. Report time to progression of distant metastases. IV. Report toxicity.
OUTLINE:
Participants receive induction chemotherapy for a minimum of 6 cycles and a maximum of 8 cycles in the absence of disease progression or unacceptable toxicity. Participants are then randomized to 1 of 2 groups.
GROUP I (MAINTENANCE CHEMOTHERAPY): Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.
GROUP II (LOCAL THERAPY): Participants receive fluorouracil and capecitabine and undergo radiation therapy (RT) per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.
After completion of study treatment, participants are followed up at 4-8 weeks, 2-3 months, every 3-6 months for up to 3 years, and then every 6-12 months thereafter.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (maintenance chemotherapy) Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. |
Drug: Capecitabine
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Other Names:
Drug: Chemotherapy
Receive induction chemotherapy
Other Names:
Drug: Fluorouracil
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Other Names:
|
| Experimental: Group II (local therapy) Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician. |
Drug: Capecitabine
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Other Names:
Drug: Chemotherapy
Receive induction chemotherapy
Other Names:
Procedure: Conventional Surgery
Undergo surgery
Drug: Fluorouracil
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
Other Names:
Radiation: Radiation Therapy
Undergo RT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [Up to 6 years]
OS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
Secondary Outcome Measures
- Local progression-free survival (PFS) [Up to 6 years]
PFS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
- Distant PFS [Up to 6 years]
PFS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.
- Incidence of adverse events [Up to 6 years]
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Time to local or regional disease recurrence [Up to 6 years]
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
Other Outcome Measures
- Time to local disease recurrence [Up to 6 years]
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
- Time to disease progression [Up to 6 years]
To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The patient has a pathologic diagnosis of tumor biopsy or fine needle aspiration (FNA) of esophageal or gastric cancer of adenocarcinoma histology
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The patient is staged with endoscopic ultrasound (EUS)/esophago-gastro-duodenoscopy (EGD) and positron emission tomography (PET)/computed tomography (CT) scan
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The patient has three or less observable metastatic lesions. 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 central nervous system (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
-
Patient Eastern Cooperative Oncology Group (ECOG) of 0-2, with life expectancy of at least 6 months
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Participants signed informed consent
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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
Exclusion Criteria:
-
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
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Patients with fistula documented radiographically or by EDG/EUS, endobronchial ultrasound (EBUS)
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Patients with life expectancy less than 6 months, ECOG > 3
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Female patients who are pregnant confirmed by beta human chorionic gonadotropin (bHCG) laboratory (lab) test
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Patient has history of uncontrolled angina, congestive heart failure or recent myocardial infarction (MI) within 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Quynh-Nhu Nguyen, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2016-0972
- NCI-2018-01202
- 2016-0972
- P30CA016672