Health TrialsbyHealthPanel

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

ConditionsClinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 chemo (immuno) therapy, chemoradiation, and esophagectomy

Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT and PET/CT scan

  • Endoscopic Ultrasound

    Procedure/Surgery

    Undergo EUS

  • Esophagogastroduodenoscopy

    Procedure/Surgery

    Undergo EGD

  • Fluorouracil

    Drug

    Given IV

  • Hypofractionated Radiation Therapy

    Radiation

    Undergo hypofractionated radiation therapy

  • Leucovorin Calcium

    Drug

    Given IV

  • Oxaliplatin

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET and PET/CT scan

  • Survey Administration

    Other intervention

    Ancillary studies

  • Docetaxel

    Drug

    Given IV

  • Durvalumab

    Biological/Vaccine

    Given IV

Treatment groups

99 Participants
are divided into 1 treatment group
Group A: Treatment (FLOT and Radiation and FOLFOX)Experimental treatment 12 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 5 years after completion of chemoradiation

Secondary outcomes

1

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.

Time frame
Up to 6 weeks after completion of chemoradiation
2

Incidence of post operative AEs

Determined by the Clavien-Dindo Classification. Will be summarized descriptively.

Time frame
From surgery up to 6 months after completion of chemoradiation
3

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.

Time frame
Up to 24 months after completion of chemoradiation
4

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.

Time frame
Up to 24 months after completion of chemoradiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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