A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma

A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma - A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047501

Enrollment

180

Registered

2022-04-18

Start date

2021-06-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamous cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The diagnosis of squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma (biopsy of the secondary lesion is not required, but if biopsy is performed, the lesion must be squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma). ECOG PS 0-2 No prior chemotherapy, radiation therapy, or surgery (Groups 1-3) (However, patients in Groups 2 and 3 are eligible if they have undergone radical therapy for at least 24 weeks after completion of treatment) Prior cisplatin (Group 4) Have evaluable lesions (evaluable lesions are defined as target and non-target lesions) Treated with FOLFOX monotherapy or chemoradiotherapy with FOLFOX between April 22, 2019 and October 31, 2020. However, patients whose doses are adjusted or reduced according to their general condition in actual clinical practice regarding the standard dosage and administration of chemoradiotherapy and chemotherapy will also be accepted for enrollment.

Exclusion criteria

Exclusion criteria: Duplicate cancers (simultaneous duplicate cancers and iatrogenic duplicate cancers with a disease-free interval of 3 years or less). However, patients with overlapping cancers that are not prognostic factors are not excluded. Patients with cardiovascular complications that are not stabilized by pharmacological therapy alone.

Design outcomes

Primary

Measure	Time frame
CR rate group 1 OS group 2, 3, 4	—

Countries

Japan

Contacts

Public ContactKazuhiro Shiraishi

National Hospital Organization Nagoya Medical Center Department of Medical Oncology

yuzushiraishi@gmail.com0529511111

Outcome results