Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Launched by MAYO CLINIC · Oct 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with esophageal or gastroesophageal junction adenocarcinoma, which is a type of cancer. The treatment combines a specific type of radiation therapy, called hypofractionated radiation, with chemotherapy drugs known as FOLFOX (which includes fluorouracil, oxaliplatin, and leucovorin). This approach aims to deliver higher doses of radiation over a shorter time to potentially kill more cancer cells while causing fewer side effects. The trial is focused on patients with stage I to III cancer who are planning to undergo surgery.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of esophageal or gastroesophageal junction adenocarcinoma. They should also be suitable for a specific type of treatment that includes chemotherapy, radiation, and surgery, and must be in good overall health. Participants can expect to receive the new treatment before surgery, with regular follow-ups to monitor their health and treatment progress. It's important to note that women who are pregnant, nursing, or not using contraception cannot participate in the study. This trial is currently recruiting participants, and those who join will also contribute to research that may help improve future cancer treatments.

Gender

ALL

Eligibility criteria

• 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 and tissue 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