Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Trial
— PHOXOfficial title:
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)
Verified date | February 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is not a chemotherapy medication but is given in conjunction with chemotherapy. Leucovorin is used with the chemotherapy medication fluorouracil to enhance the effects of the fluorouracil, in other words, to make the drug work better. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Giving preoperative hypofractionated radiation with fluorouracil and oxaliplatin may kill more tumor cells in patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma.
Status | Recruiting |
Enrollment | 99 |
Est. completion date | November 30, 2026 |
Est. primary completion date | May 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0 - Candidate for trimodality therapy: neoadjuvant chemotherapy, chemoradiation, and esophagectomy - Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Negative pregnancy test done = 7 days prior to chemotherapy, for women of childbearing potential only - Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance - Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - Willing to provide blood samples for correlative research purposes Exclusion Criteria: - Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1) - Cervical or upper esophageal tumor - Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of adverse events - Receiving any investigational agent which would be considered as a treatment for the primary neoplasm or other active malignancy = 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic complete response | A single-group design will be used to test whether the proportion is potentially non-inferior, with a non-inferiority proportion (P0) of 0.13 (H0: P = 0.13 versus H1: P > 0.13). | Up to 5 years after completion of chemoradiation | |
Secondary | Incidence of acute = gastrointestinal (GI) adverse events (AEs) | Report acute grade = 3 GI AEs per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. Will be summarized descriptively. | Up to 6 weeks after completion of chemoradiation | |
Secondary | Incidence of post operative AEs | Determined by the Clavien-Dindo Classification. Will be summarized descriptively. | From surgery up to 6 months after completion of chemoradiation | |
Secondary | Patient-reported quality of life (QOL) | Per Functional Assessment of Cancer Therapy- Esophageal. Will be assessed over time. Wilcoxon signed-rank tests will be used to calculate p-values. Descriptive statistics and graphical methods will also be used to summarize the data. | Up to 24 months after completion of chemoradiation | |
Secondary | Financial toxicity | Financial toxicity will be measured using the COmprehensive Score for financial Toxicity (COST), a patient-reported outcome measure that describes the financial distress experienced by cancer patients. The survey consists of 12 questions, each answered with a 0-4 scale where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, and 4=Very much. Results will be reported descriptively and include separate consideration of individual item scores. | Up to 24 months after completion of chemoradiation | |
Secondary | Overall survival (OS) | Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc. | From study entry to death from any cause, up to 5 years after completion of chemoradiation | |
Secondary | Progression-free survival (PFS) | Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc. | From study entry to the first of either disease progression or death, up to 5 years after completion chemoradiation | |
Secondary | Long-term toxicity secondary to trimodality therapy | Will be reported descriptively using CTCAE version 5.0 criteria. | Up to 5 years after completion of chemoradiation | |
Secondary | Event free survival | Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc. | From study entry to the first of either disease progression or recurrence or relapse or death, up to 5 years after completion of chemoradiation | |
Secondary | Outcomes for patients treated with hypofractionated radiotherapy and FOLFOX but who did not proceed to esophagectomy | OS and PFS will be assess using Kaplan-Meier methodology. Summary statistics will be reported, including medians, 95% confidence intervals, etc. AEs and QOL data will be reported with summary statistics and graphical methods, as appropriate. | Up to 5 years after completion of chemoradiation | |
Secondary | Toxicity of chemoradiation between patients receiving proton based versus photon-based radiotherapy | Will be done descriptively, reporting frequencies and percentages between patients. | Up to 5 years after completion of chemoradiation | |
Secondary | Toxicity of chemoradiation between groups receiving proton based versus photon-based radiotherapy | Will be done descriptively, reporting toxicity rates between groups using the chi-square test. | Up to 5 years after completion of chemoradiation |
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