UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034543
Receipt number R000039380
Scientific Title Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer
Date of disclosure of the study information 2018/11/01
Last modified on 2023/10/21 10:29:20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer

Acronym

Phase I Dose-Escalation Study of AHF and IMRT in Patients with Locally Advanced NSCLC

Scientific Title

Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer

Scientific Title:Acronym

Phase I Dose-Escalation Study of AHF and IMRT in Patients with Locally Advanced NSCLC

Region

Japan


Condition

Condition

Non-small cell lung carcinoma (NSCLC)

Classification by specialty

Pneumology Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the maximum tolerated dose and to determine the recommended dose of accelerated hyperfractionation and intensity-modulated radiation therapy for locally advanced NSCLC

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of Grade 3 or more acute adverse events within 90 days after chemoradiotherapy

Key secondary outcomes



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

Medicine

Interventions/Control_1

Chemoradiotherapy consists of CBDCA (AUC2, day 1, 8, 15, 22), PTX (40 mg/m2, day 1, 8, 15, 22) and AHF and IMRT (56-72 Gy/40 fr:56 Gy/40 fr at level 0, 60 Gy at level 1, 64 Gy at level 2, 68 Gy at level 3 and 72 Gy at level 4)

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically proven NSCLC
2) Clinical stage IIIA or IIIB Locally Advanced NSCLC
3) Aged 20 to 90 years old, ECOG Performance status 0 or 1
4) Without previous chemotherapy for primary illness
5) Without previous radiotherpy for chest
6) Adequate organ functions
7) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) With severe complications
4) History of serious drug allegies
5) Patients with unstable and uncontrollable diabetic mellitus, hypertension, kidney disease, liver disease.
6) Patients with intersitial pneumonia or pulmonary fibrosis detectable on chest radiography
7) Women during pregnancy or breast-feeding, or patients who wish pregnancy
8) Patients that physicians consider inappropriate for this study

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Noriko
Middle name
Last name Kishi

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code

606-8507

Address

54 Shogoin Kawaharacho Sakyo-ku, Kyoto

TEL

0757513762

Email

kishin@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Kishi

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code

606-8507

Address

54 Shogoin Kawaharacho Sakyo-ku, Kyoto

TEL

075-751-3762

Homepage URL


Email

kishin@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University

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

Graduate School of Medicine, Kyoto University, Ethics Committe

Address

54 Shogoin Kawaharacho Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.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

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2018 Year 05 Month 09 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2025 Year 05 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 17 Day

Last modified on

2023 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name