Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
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| ClinicalTrials.gov Identifier: NCT03161522 |
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Recruitment Status :
Recruiting
First Posted : May 19, 2017
Last Update Posted : March 23, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Adenocarcinoma Oligometastasis Stage IV Esophageal Adenocarcinoma AJCC v7 Stage IV Esophageal Cancer AJCC v7 Stage IV Gastric Cancer AJCC v7 | Drug: Capecitabine Drug: Chemotherapy Procedure: Conventional Surgery Drug: Fluorouracil Radiation: Radiation Therapy | Phase 2 |
PRIMARY OBJECTIVES:
I. 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:
I. Assess the relationships between progression-free survival and overall survival between both treatment arms.
II. 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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases |
| Actual Study Start Date : | February 19, 2018 |
| Estimated Primary Completion Date : | July 31, 2023 |
| Estimated Study Completion Date : | July 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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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:
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- Overall survival (OS) [ Time Frame: 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.
- Local progression-free survival (PFS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 6 years ]Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Time to local or regional disease recurrence [ Time Frame: Up to 6 years ]To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
- Time to local disease recurrence [ Time Frame: 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 [ Time Frame: Up to 6 years ]To be analyzed by Bayesian piecewise regression to assess their relationships with treatment arm and prognostic covariates.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion 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 observable metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization.
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 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 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.
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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161522
| Contact: Quynh Nhu Nguyen, MD | 713-563-2300 | qnnguyen@mdanderson.org |
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Quynh-Nhu Nguyen 713-563-2300 | |
| Principal Investigator: Quynh-Nhu Nguyen | |
| Principal Investigator: | Quynh-Nhu Nguyen | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03161522 |
| Other Study ID Numbers: |
2016-0972 NCI-2018-01202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2016-0972 ( Other Identifier: M D Anderson Cancer Center ) |
| First Posted: | May 19, 2017 Key Record Dates |
| Last Update Posted: | March 23, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Adenocarcinoma Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Fluorouracil Capecitabine Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |