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Neoadjuvant chemoradiotherapy with protons for resectable esophageal cancer

A phase II study of neoadjuvant chemoradiotherapy with protons for resectable esophageal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0005576
Enrollment
68
Registered
2020-11-04
Start date
2020-11-17
Completion date
Unknown
Last updated
2020-12-02

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

Conditions

None listed

Interventions

Drug, Radiation : [Radiotherapy] Total 44Gy (2.0Gy x 22 times_during 5 weeks) GTV1: Gross disease (primary tumor + node metastasis) CTV1: GTV1 + safety margin (cranio-caudal [YS1] 3-5 cm + circumfer

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - ECOG 0~2 - Good Organ Function (1) Absolute neutrophil count > 1500/mm3, platelets =100,000/mm3, Hemoglobin = 9g/dl (2) CCr = 20mL/min (Cockroft-Gautl)) (3) Total billrubin =1.5X UNL, AST /ALT =2.5X UNL - FEV1> 1.5L - Singed Informed Consesnt

Exclusion criteria

Exclusion criteria: 1. Have a history of esophageal Cancer who previously received topical therapy such as esophageal submucosal resection, surgery, radiation therapy or chemotherapy. 2. Have a distant metastasis lesion 3. Have a history of severe hypersenstivity to mannitol, paclitacxel, neoplatin or platinum based durg. 4. Have a hearing damage. 5. Have a hemorrhagic tumor 6. Have a additional malignancy is not disease free for more than 3 years. (except cured basal or smuamous skin cancer, cervial carcinoma in situ) 7. pregnant or breastfeeding 8. uncontrolled pychiatric disease, severy head injury, chronic alcoholism or drug addiction. CNS disease. 9 Have a weight loss of more than 10% during recent 6 months

Design outcomes

Primary

MeasureTime frame
Overall Best Response rate

Secondary

MeasureTime frame
Safety evaluation

Countries

Korea, Republic of

Contacts

Public ContactYoungJoo Lee

National Cancer Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026