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A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer

A clinical study comparing carbon-ion radiotherapy and surgery for small-sized peripheral non-small cell lung cancer - A clinical study comparing carbon-ion radiotherapy and surgery for non-small cell lung cancer(iROCK-1504LU)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023183
Enrollment
525
Registered
2016-08-01
Start date
2016-08-01
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

Small-sized peripheral non-small cell lung cancer with clinical stage IA

Interventions

Carbon-ion therapy Surgical removal

Sponsors

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients meet the following criteria(a-j). (a)Contrast-enhanced thoracic CT fulfills all of the following conditions (1)single tumor (2)non-small cell lung cancer (3)Center of tumor is located in the outer third of the peripheral lung field (4)no finding of metastasis of reginal lymph node (b)Thin-section CT fulfills either following conditions (1)maximum diameter of the tumor is 2cm or less (2)less than 3cm of the tumor size and less than 0.5 of consolidation tumor ratio (c)Age 20 to 79 years old (d)No prior ipsilateral thoracotomy (e)No prior chemotherapy or radiation therapy for any malignant diseases (f)Lobectomy tolerable (g)0 or 1 of performance status (h)Sufficient organ functions (i)38centigrade or less of preoperative body temperature (j)Written informed consent obtained

Exclusion criteria

Exclusion criteria: All patients must NOT meet the following criteria. a)Active bacterial or fungous infection b)Simultaneous or metachronous (within the past 5 years) double cancers c)Women during pregnancy or breast-feeding d)Interstitial pneumonia, lung fibrasis or severe emphysema e)Psychosis or psychiatric condition unsuitable for carbon-ion ratiotherapy or surgery f)Systemic steroids medication g)Intractable diabetes mellitus. h)Intractable hypertension i)History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months j)Metal devices in the lesion k)Other medical or psychological condition which is unsuitable for carbon-ion radio therapy or surgery

Design outcomes

Primary

MeasureTime frame
Five-year overall survival

Secondary

MeasureTime frame
a) Relapse-free survival, Cause-specific survival b) Local recurrence c) Adverse reaction d) Respiratory function post-surgery or carbon-ion therapy e) Length of hospital stay

Countries

Japan

Contacts

Public ContactHiroyuki Katoh

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center

hkatoh@kcch.jp045-520-2222

Outcome results

None listed

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