Non-small cell lung cancer without regional lymph node involvement or distant metastasis
Conditions
Interventions
Based on the tumor characteristics and patient background, the most appropriate treatment protocol shall be selected from the options below. Proton beam therapy will be administered once daily, five d
Sponsors
Sakurai Hideyuki
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility Criteria for Patients Scheduled to Undergo Definitive Proton Therapy Alone for Localized Lung Cancer at Our Institution 1. Written informed consent has been obtained from the patient prior to participation in the study. 2. The patient is 18 years of age or older at the time of consent. 3. The patient's Eastern Cooperative Oncology Group (ECOG) Performance Status is 0 to 2. 4. The patient has been diagnosed with primary lung cancer based on histological examination, or has been clinically diagnosed with lung cancer. 5. Based on physical examination and/or CT or PET-CT findings, the clinical stage is T1-4N0M0 according to the 8th edition of the UICC/TNM classification.
Exclusion criteria
Exclusion criteria: 1. Patients who have serious comorbidities such as severe infections, congestive heart failure, acute myocardial infarction, respiratory failure, hepatic failure, renal failure, acute cerebrovascular disease, or uncontrolled diabetes mellitus. 2. Patients who have active multiple primary cancers at the time of consent. Active multiple cancers are defined as synchronous or metachronous cancers diagnosed within a disease free interval of less than five years, or cancers that currently require treatment. However, the following cases are not regarded as active multiple cancers. These include clinical stage 0 or I laryngeal cancer that achieved complete response with radiotherapy, and completely resected cancers with a five year relative survival rate of 95 or more. Eligible cancers include pathological stage 0 to I gastric cancer with adenocarcinoma of intestinal type, stage 0 to I colon cancer with adenocarcinoma, stage 0 to I rectal cancer with adenocarcinoma, stage 0 esophageal cancer with squamous cell carcinoma, adenosquamous carcinoma, or basaloid carcinoma, stage 0 breast cancer with ductal carcinoma in situ or lobular carcinoma in situ, stage 0 to IIA breast cancer with invasive ductal carcinoma, invasive lobular carcinoma, or Paget disease, stage I endometrial cancer with endometrioid adenocarcinoma or mucinous adenocarcinoma, stage I to II prostate cancer with adenocarcinoma, stage 0 cervical cancer with squamous cell carcinoma, stage I to III thyroid cancer with papillary carcinoma or follicular carcinoma, stage I renal cancer with clear cell carcinoma or chromophobe cell carcinoma, and other lesions equivalent to carcinoma in situ. 3. Patients who have intractable inflammatory disease within the irradiation field. 4. Patients who have systemic inflammatory disease that requires treatment. 5. Patients who are unable to understand the treatment due to severe cognitive impairment including advanced dementia. 6. Patients for whom dose constraints for organs at risk cannot be satisfied in treatment planning. 7. Patients who are judged to be unsuitable for participation in the study by the principal investigator or sub investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of acute and late adverse events 2. 3 year local control rate 3. 3 year progression free survival rate 4. 5 year overall survival rate 5. 5 year local control rate 6. 5 year progression free survival rate | — |
Contacts
Public ContactMasatoshi Nakamura
University of Tsukuba Hospital
Outcome results
None listed