Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
About this trial
This is an interventional treatment trial for Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Eligibility Criteria
Inclusion Criteria:
- REGISTRATION TO STEP 1
- Patient must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma (American Joint Committee on Cancer [AJCC] 8th edition)
Patient must have oligometastatic disease at the time of registration, which is defined as the following:
- At most 3 radiologically visible metastatic lesions (not sites), in addition to the primary site. Computed tomography (CT) or magnetic resonance imaging (MRI) scans will be performed for staging purposes. Patients with oligometastatic sites that are only detected with positron emission tomography (PET)/CT will be eligible for participation, as long as radiation planning and administration is feasible after discussion with treating radiation oncologist. Malignant lymph node should be at least 1 cm in size or biopsy proven involved by disease
- Anatomically defined lymphadenopathy will be considered as 1 site of metastatic disease. For example, 2 enlarged paraaortic lymph nodes will be considered as one site, and 2 additional sites will be allowed to meet protocol definition of oligometastatic disease. However, if supraclavicular or cervical nodes are involved for distal esophageal tumors or gastric tumors, these are counted separately from intrathoracic nodes. For upper thoracic/cervical esophageal tumors, the involvement of celiac nodes are counted separately from intrathoracic nodes. Intrathoracic nodes, defined as hilar and mediastinal nodes, will be collectively counted as one
- Patients with radiologically evident peritoneal metastasis will be excluded.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception (both double barrier contraception and birth control pills or implants) or by abstaining from sexual intercourse for at least one month after the last dose of protocol treatment and continuing for 5 months after the last dose of protocol treatment (for female patients) and for 7 months after the last dose of protocol treatment (for male patients who are sexually active with women of child bearing potential [WOCBP]). Investigators must counsel WOCBP and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained within 28 days prior to registration)
- Hemoglobin >= 8 g/dL (obtained within 28 days prior to registration)
- Platelets (PLT) >= 100 x 10^9/L (obtained within 28 days prior to registration)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN) (obtained within 28 days prior to registration)
- Bilirubin =< 1.5 x institutional ULN (obtained within 28 days prior to registration)
- Serum creatinine =< 1.5 x institutional ULN (Cockcroft and Gault formula) (obtained within 28 days prior to registration)
- Albumin > 2.5 g/dL (obtained within 28 days prior to registration)
- Patient must be able to understand and willing to sign and date the written voluntary informed consent form prior to any protocol-specific procedures
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must have CD4 > 200 at the time of registration
- NOTE: HIV testing is not required for eligibility
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients who had prior definitive treatment for early stage EGA with either surgery or chemoradiation are eligible for participation as long as recurrent disease developed at least 6 months after completion of all prior therapies
- Any major surgery must have been completed >= 4 weeks prior to registration
- REGISTRATION TO STEP 2
- Patient must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma (AJCC 8th edition) with stable disease after about 4 months of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) or 6 cycles of capecitabine and oxaliplatin (CAPOX) (Step 1 treatment)
- Patient must have no evidence of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria since Step 1 registration. Patients with complete radiologic response are eligible for Step 2
- Patient must have an ECOG performance status 0-1
Exclusion Criteria:
- Patient must not have any contraindications to 5-fluorouracil (5-FU) or capecitabine, oxaliplatin
- Patient must not have any contraindications to radiation therapy based on consultation with a radiation oncologist. Formal radiation oncology evaluation will be required for eligibility purposes. Prior palliative or definitive radiation to the primary site is allowed, as long as it was completed at least 2 weeks before registration
Women must not be pregnant or breast-feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
- All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 14 days prior to registration
- A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient must not have had any prior treatment with 5-FU or capecitabine and/or oxaliplatin containing systemic therapy
- NOTE: Patients previously treated with radiosensitizing doses of 5-FU will be eligible for participation as long as adequate time has elapsed from past treatments
- NOTE: Patients who received systemic 5-FU or capecitabine and/or oxaliplatin as part of the treatment for their locoregional disease are eligible for participation, as long as all definitive therapy has been completed at least 6 months prior to trial enrollment
- Patients with known central nervous system (CNS) metastasis will be excluded from trial participation, regardless of the status of the CNS disease
- Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patient must not have had live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed
Sites / Locations
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy CenterRecruiting
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Kingman Regional Medical CenterRecruiting
- Mercy Hospital Fort SmithRecruiting
- PCR OncologyRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Salinas Valley MemorialRecruiting
- MedStar Georgetown University HospitalRecruiting
- Holy Cross Hospital
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial HospitalRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Saint Anthony's HealthRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- University of IllinoisRecruiting
- Carle on VermilionRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Loyola Medicine Homer GlenRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Southwest Illinois Health Services LLP
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Reid HealthRecruiting
- Saint Anthony Regional HospitalRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Iowa Lutheran HospitalRecruiting
- Trinity Regional Medical CenterRecruiting
- Methodist West HospitalRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- MaineHealth Coastal Cancer Treatment CenterRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-BiddefordRecruiting
- Maine Medical Center-Bramhall CampusRecruiting
- MaineHealth Cancer Care Center of York CountyRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-SanfordRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Mercy Medical Center
- Saint Joseph Mercy HospitalRecruiting
- Bronson Battle CreekRecruiting
- McLaren Cancer Institute-Bay City
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- McLaren Cancer Institute-Clarkston
- Newland Medical Associates-ClarkstonRecruiting
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Weisberg Cancer Treatment Center
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe WoodsRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Karmanos Cancer Institute at McLaren Greater Lansing
- Mid-Michigan Physicians-Lansing
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer Region
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb TownshipRecruiting
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- McLaren-Port Huron
- Spectrum Health Reed City HospitalRecruiting
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Metro Health HospitalRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges HospitalRecruiting
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical CenterRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Fairview Lakes Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-HendersonRecruiting
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical CenterRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical CenterRecruiting
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford South University Medical CenterRecruiting
- Southpointe-Sanford Medical Center FargoRecruiting
- Sanford Medical Center FargoRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- First Dayton Cancer Care
- Kettering Medical CenterRecruiting
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical CenterRecruiting
- Saint Joseph Warren HospitalRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Saint Alphonsus Medical Center-Baker CityRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-RedmondRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Bryn Mawr HospitalRecruiting
- Main Line Health Center-CollegevilleRecruiting
- Pocono Medical CenterRecruiting
- Main Line Health Center-ExtonRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Riddle Memorial HospitalRecruiting
- Paoli Memorial HospitalRecruiting
- Reading HospitalRecruiting
- Lankenau Medical CenterRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Parkland Memorial HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Providence Regional Cancer PartnershipRecruiting
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-LaceyRecruiting
- PeaceHealth Saint John Medical CenterRecruiting
- Valley Medical CenterRecruiting
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard CampusRecruiting
- Swedish Medical Center-Cherry HillRecruiting
- Swedish Medical Center-First HillRecruiting
- PeaceHealth United General Medical CenterRecruiting
- Providence Regional Cancer System-SheltonRecruiting
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-YelmRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Billings Clinic-CodyRecruiting
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Arm A (FOLXFOX)
Arm B (CAPOX)
Arm C (radiation therapy, FOLFOX)
Arm D (FOLFOX)
Arm E (radiation therapy, CAPOX)
Arm F (CAPOX)
Patients receive oxaliplatin IV over 1.5 hours, leucovorin IV over 1.5 hours, and 5-fluorouracil IV over 46-48 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
One week post induction of patients in ARM A, patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients receive oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable toxicity.
Post induction of patients in ARM A, patients continue oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable toxicity.
One week post induction of patients in ARM B, patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients receive oxaliplatin and capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.
Post induction of patients in ARM B, patients continue oxaliplatin and capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.