UMIN-CTR Clinical Trial

Public title

A phase I/II clinical trial of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix

Acronym

Carbon-ion radiotherapy and concurrent chemotherapy for locally advanced adenocarcinoma of the uterine cervix

Scientific Title

A phase I/II clinical trial of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix

Scientific Title:Acronym

Carbon-ion radiotherapy and concurrent chemotherapy for locally advanced adenocarcinoma of the uterine cervix

Region

Japan

Condition

locally advanced adenocarcinoma of the uterine cervix

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Phase I study
Acute toxicity (to determine the maximum tolerated dose and the recommended dose for phase II study)
Phase II study
Response rate

Key secondary outcomes

Phase I study
Response rate at the RD level
Phase II study
Acute and late toxicity
Local control
Progression-free survival
Overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A total dose of 68.0-74.4 GyE in 20 fractions of carbon-ion radiotherapy is administered for 5 weeks.
Cisplatin 40mg/m2 is administered weekly for 5 weeks concurrently with carbon-ion radiotherapy.

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

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Female

Key inclusion criteria

1. Pathologically proven adenocarcinoma or adenosquamous carcinoma of the uterine cervix
2. Stage IIB, III, or IVA disease (FIGO 1994)
3. No enlarged para-aortic lymph node by CT scan
4. Measurable disease
5. Age; 20-70 years
6. PS; WHO 0-2
7. Patients with unresectable disease or patients who refuse surgery
8. No prior surgery or chemotherapy to cervical cancer
9. Adequate bone marrow, hepatic, and renal functions;
white blood cells >= 3000/m3
hemoglobin >= 10g/dl
platelets >= 100,000/m3
total bilirubin <= 1.5mg/dl
AST/ALT <= 100IU/dl
serum creatinine <= 1.5mg/dl
creatinine clearance >= 50ml/min
ECG: within normal range
10. Life expectancy; longer than 6 months
11. Written informed consent

Key exclusion criteria

1. Severe concomitant illness (e.g. uncontrolled heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infectious disease, active gastric ulcer, uncontrolled mental illness)
2. History of other malignancies within the past 5 years
3. Tumor invading directly to the rectum
4. Prior radiotherapy to the pelvis
5. Patients who are judged inappropriate for the entry into the study by the investigator

Target sample size

32

Name of lead principal investigator

1st name
Middle name
Last name	Shingo Kato

Organization

National institute of radiological sciences of Japan

Division name

Research center for charged particle therapy

Zip code

Address

4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

National institute of radiological sciences of Japan

Division name

Research center for charged particle therapy

Zip code

Address

4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan

TEL

043-206-3360

Homepage URL

Email

Institute

Research center for charged particle therapy, National institute of radiological sciences of Japan

Institute

Department

Personal name

Organization

MEXT Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2010

Year

03

Month

25

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

05

Month

09

Day

Last modified on

2010

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004344