Hypofractionated Radiotherapy With Folfox for Esophageal/Gej Adenocarcinoma

Overview

About this study

The purpose of this study is to demonstrate non-inferiority of pCR with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/15/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christopher Hallemeier, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Michael Rutenberg, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available