Prospective Multicenter Observational Study of Esophageal Preservation Survival in definitive Chemoradiotherapy +/- Photodynamic Therapy for Esophageal Cancer

Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study - NEC2P2 Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043767

Enrollment

150

Registered

2021-07-06

Start date

2021-09-01

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 Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with Stage I-IVa esophageal cancer diagnosed by imaging or histological diagnosis, who are inoperable or do not wish to undergo surgery. 2) Patients who are scheduled to undergo dCRT of 50.4 Gy or more. 3) Histologically proven esophageal cancer (any of the common histological types) by endoscopic biopsy of the primary esophageal tumor. 4) Patients must have adequate organ function, and if combination chemotherapy is to be administered, either the regimen described in the Guidelines for the Treatment of Esophageal Cancer or fluorouracil plus levofolinate plus oxaliplatin (FOLFOX) is available and will be administered as first-line therapy. 5) Patients must be at least 20 years old at the time of consent. 6) PS (ECOG) is either 0, 1, or 2. 7) Written consent for participation in the study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1) Women who are pregnant, may become pregnant (intentionally), or are breastfeeding. Men who wish their partner to become pregnant. 2) Patients with concomitant psychosis or psychiatric symptoms that would make it difficult to participate in the study. 3) Patients with active bacterial and fungal infections (fever of 38 degrees or higher, and bacterial infection documented by imaging or bacteriological examination. (Local infections that do not affect the systemic condition are excluded. 4) Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 5) History of myocardial infarction or unstable angina within 6 months of enrollment. 6) Patients with poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 7) Other patients who are judged by the physician in charge to be unable to tolerate the treatment prescribed in this study.

Design outcomes

Primary

Measure	Time frame
3-year esophageal preservation survival, 5-year esophageal preservation survival of I-IVa esophageal cancer radical (chemo)radiation therapy plus salvage PDT	—

Countries

Japan

Contacts

Public ContactNobuhito Ito

Nagoya University Gastroenterology

nito@med.nagoya-u.ac.jp052-744-2172

Outcome results