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Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma

Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma - Phase II study of salvage PDT for esophageal carcinoma

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000244
Enrollment
37
Registered
2005-09-22
Start date
2005-02-01
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 squamous cell carcinoma

Interventions

Photodynamic therapy

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with esophageal squamous cell carcinoma who were treated with defenitive chemoradiotherapy 2) Patients` refusal of salvage surgery 3) assessed cancerous lesion limited within the submucosal layer by EUS 4) histolical confirmation of squamous cell carcinoma from the lesion 5) Performance status(ECOG): 0, 1, 2 6) Written informed consent 7) adequate organ function, defined as; WBC; 3000-12000/mm3, platelet count; >100000/mm3, serum creatinine level <1.5mg/dl, serum bilirubin level<2.0mg/dl, serum transaminase<100IU/l

Exclusion criteria

Exclusion criteria: 1) No other active malignancy 2) No other severe medical conditions 3) Patients who are suffered systemic infection 4) Patients who cannot keep shading 5) Lesions were judged within mucosal laiyer, and can be treated with EMR 6) Lesions were assessed as T4 before CRT. 7) clinically defined distant or lymph node metastasis by computed tomography and endoscopic ultrasound (EUS) before PDT 8) Patients with porphyria 9) Lesions were not completely evaluated because of stenosis after CRT

Design outcomes

Primary

MeasureTime frame
Complete response rate of primary site

Secondary

MeasureTime frame
Occurence rate of adverse event Progression free survival Overall survival

Countries

Japan

Contacts

Public ContactTomonori Yano

National Cancer Center Hospital East Division of digestive endoscopy and GI oncology

toyano@east.ncc.go.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026