UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045505 |
|---|---|
| Receipt number | R000051875 |
| Scientific Title | A phase 2 study of proton therapy for operable stage I non-small cell lung cancer |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/08/12 19:07:37 |
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Basic information
Public title
A phase 2 study of proton therapy for operable stage I non-small cell lung cancer
Acronym
Proton therapy for operable stage I non-small cell lung cancer
Scientific Title
A phase 2 study of proton therapy for operable stage I non-small cell lung cancer
Scientific Title:Acronym
Proton therapy for operable stage I non-small cell lung cancer
Region
| Japan |
Condition
Condition
Stage I non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of proton therapy for stage I non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year overall survival rate
Key secondary outcomes
The rate of grade 3 and higher radiation pneumonitis within 180 days after the start of irradiation, local control rate, progression-free survival period, event-free survival period, local progression-free survival period, patterns of failure, adverse event, QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Proton therapy (66 GyRBE in 10 fractions over 2 weeks or 72.6 GyRBE in 22 fractions over 4.4 weeks)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
2) Clinical stage IA or IB (7th edition of TNM staging of Union for International Cancer Control) within 28 days
3) ECOG peformance status of 0-2
4) Age>=20 and <80
5) Capable of maintaining their position during irradiation
6) Dose constraints of the organs at risk seem to be limited within range
7) No previous radiotherapy around the lesion
8) No previous chemotherapy
9) Operable judged by the surgeon
10) Who refuse surgery, even if tumors could be cured by surgery
11)Respiratory function (<=28 days) PaO2 in room air >=65 Torr and forced expiratory volume 1.0 >=800 mL
12) Written informed consent
Key exclusion criteria
1) Pregnancy
2) Synchronous or metachronous cancer
3) Active infectious disease
4) Other severe comorbidities
5) Severe psychological disorder
6) Apparent interstitial pneumonitis or pulmonary fibrosis detectable by chest X-ray radiography
7) Judged as inappropriate to participation by investigators
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogino |
Organization
Nagoya city University West Medical Center, Nagoya Proton Therapy Center
Division name
Radiation oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL
052-991-8577
oginogio@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Nakajima |
Organization
Nagoya city University West Medical Center, Nagoya Proton Therapy Center
Division name
Radiation oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL
052-991-8577
Homepage URL
k.nakajima.ncu@gmail.com
Sponsor or person
Institute
Nagoya City University West Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Study Committees of the Nagoya City Hospital
Address
1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel
052-721-7171
rinsho1@higashi-hosp.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.radonc.2024.110276
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.radonc.2024.110276
Number of participants that the trial has enrolled
43
Results
IGPT yielded 3-year overall survival and local control rates of 95% each, with 7-year rates of 83% and 95%, respectively.
Grade 3 radiation pneumonitis was observed in one case (2.3%).
Quality of life (QOL) analysis revealed IGPT effectively maintained overall QOL; however, about 40% patients reported dyspnea after treatment.
Results date posted
| 2024 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 43 patients were enrolled from July 2013 to January 2021. Characteristics of the patients, tumors, and treatments are summarized in Table 1. The median age was 68 years (range, 47-79 years), and 20 (47%) patients were men. All patients had a performance status of 0. Clinical stages based on UICC 7th were IA in 27 (63%) and IB in 16 (37%) patients. Thirty-eight (88%) patients had adenocarcinoma. Forty-one (95%) patients had peripherally located tumors and two patients (5%) had centrally located tumors.
Participant flow
A total of 43 patients were enrolled from July 2013 to January 2021.
Adverse events
No grade 3 or higher RP occurred within 180 days. Four patients (9%) developed grade 2 symptomatic RP at 2 to 5 months; all patients received steroids and their symptoms improved. One patient (2%) developed grade 3 RP at 11 months, requiring hospitalization. No other grade 3 or higher adverse events were observed.
Outcome measures
IGPT offered operable stage I NSCLC 3-year OS and LC rates of 95% each, with 7-year rates of 83% and 95%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051875
