5

iPLAS
症例報告書
（ CRF ； Case Report Form ）
プラチナ感受性再発上皮性卵巣癌・原発性卵管癌・腹膜癌に対する
リポソーム化ドキソルビシン＋カルボプラチン療法と
ゲムシタビン＋カルボプラチン療法
に関するランダム化第II相臨床試験
iPLASでは、EDC（Electronic Data Capture）システムMedidata Rave®を使用しデータを収集します。
本CRFは、どのような項目についてデータ収集するのかということをご覧いただくための見本ですので、
実際のEDC入力画面とはレイアウトが異なりますことをご了承ください。
<iPLAS Form schedule >
PLDC群
Sheet
No.
1
2
3
4
5
6
7
8
9
10
GC群
Sheet
No.
1
2
3
4
5
6
7
8
9
10
Cycle
Day
Patient Registration
Disease Information
Medical History
Hepatitis Screening
Baseline Findings
Surgical Report
Physical Examination
Laboratory Examination
Biomarkers
Dosage Administration Record(Day1)
Dosage Administration Record(Day8)
Adverse Events
Supportive Care
Target Lesions
Non-Target Lesions
Tumor Evaluation
End of Study
Toxicity Assessment
Follow Up
Non-Protocol Therapy
Before
Registration
Cycle
Day
Patient Registration
Disease Information
Medical History
Hepatitis Screening
Baseline Findings
Surgical Report
Physical Examination
Laboratory Examination
Biomarkers
Dosage Administration Record(Day1)
Dosage Administration Record(Day8)
Adverse Events
Supportive Care
Target Lesions
Non-Target Lesions
Tumor Evaluation
End of Study
Toxicity Assessment
Follow Up
Non-Protocol Therapy
Before
Registration
1
1
8
2
15
22
1
8
3
15
22
1
8
4
15
22
1
8
5
15
22
1
8
6
15
22
1
8
15
22
End of Study
Follow Up
✔
✔
(✔)*1
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
(✔)*2
(✔)*2
(✔)*2
(✔)*2
(✔)*2
(✔)*2
(✔)*3
✔
✔
1
1
8
15
1
2
8
15
1
3
8
15
1
4
8
15
1
5
8
15
1
6
8
15
End of Study
Follow Up
✔
✔
(✔)*1
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
(✔)*2
(✔)*2
(✔)*2
(✔)*2
(✔)*2
(✔)*2
(✔)*3
✔
✔
*1　初回手術施行例のみ提出して下さい
*2　8週毎(±1週間)に画像検査を行い、該当するサイクルへ入力して下さい
*3　増悪が確認された後は、入力不要です
iPLAS_version1.0
1
登録時にデータセンターが入力します
◆Arm
◆Date of Registration
◆Weight
◆Height
◆Date of Birth
◆Treatment Free Interval
◆Histologic type
◆Patient Identification Number
◆Patient Initials First
◆Patient Initials Last
□PLDC　□GC
mm/dd/yyyy
mm/dd/yyyy
□6-12months　□Over 12months
□Clear cell carcinoma or Mucinous adenocarcinoma　□Other
（非公開の場合はXと入力）
（非公開の場合はXと入力）
iPLAS_version1.0
2
◆ DISEASE INFORMATION
20
[1] Primary Site
1 □ Epithelial ovarian
[2] Date of Primary Diagnosis
2
m
20
□ Primary fallopian tube
d
3
□ Peritoneal
y
[3] Histologic type (check one)
108 □ Serous adenocarcinoma
107 □ Mucinous adenocarcinoma
105 □ Endometrioid carcinoma
104 □ Clear cell carcinoma
88 □ Other, specify:
CANCER THERAPY FOR CURRENT CANCER
[1] Primary Surgery
1 □ Yes → Fill in SURGICAL REPORT on Form S
2
□ No → Clinical Stage
(FIGO stage)
□ 1A
□ 3A
1
7
2
8
□ 1B
□ 3B
3
9
□ 1C
□ 3C
4
10
□ 2A
□4
5
□ 2B
6
□ 2C
[2] Prior Chemotherapy
End date
1
□ TJ
2
□ TJ-Weekly
3
□ DC
4□Other(
20
)
m
d
y
NOTICE OF PROGRESSION
[1] Date of progression / recurrence at this time
20
m
d
y
20
◆ MEDICAL HISTORY
[1] Previous
Disease/Diagnosis/Surgery
or current diseases other than primary cancer
[2] Current disease?
1
1
□
No
2
□ Yes
2
1
□
No
2
□ Yes
3
1
□
No
2
□ Yes
4
1
□
No
2
□ Yes
5
1
□
No
2
□ Yes
◆HEPATITIS SCREENING
2 0
m
1
HBsAg
d
y
1□
－
2□
＋ 2 HBsAb
1□
－
2□
＋ 3 HBcAb
1□
－
2□
＋
iPLAS_version1.0
3
◆ BASELINE FINDINGS
Please record current abnormal physical findings or ongoing symptoms.
[1]
No.
CTC Term
[2] CTCAE
（CTCAE Version.4）
grade
1 WBC↓
0 1 2 3 4
2 ANC↓
0 1 2 3 4
3 Platelets↓
0 1 2 3 4
4 Bilirubin↑
0 1 2 3 4
5 AST/SGOT↑
0 1 2 3 4
6 ALT/SGPT↑
0 1 2 3 4
7 Albumin↓
0 1 2 3 4
8 Creatinine↑
0 1 2 3 4
9 Na↓
0 1 2 3 4
10 K↓
0 1 2 3 4
11 Anemia
0 1 2 3 4
12 Allergic reaction
13 Anorexia
0 1 2 3 4
14 Nausea
0 1 2 3 4
15 Vomiting
0 1 2 3 4
16 Constipation
0 1 2 3 4
17 Diarrhea
0 1 2 3 4
18 Mucositis oral
0 1 2 3 4
19 Rash/Hand-foot skin reaction
0 1 2 3 4
20 Peripheral motor neuropathy
0 1 2 3 4
21 Peripheral sensory neuropathy
0 1 2 3 4
22 Fever
0 1 2 3 4
23 Febrile neutropenia
0 1 2 3 4
24 Alopecia
0 1 2 3 4
25 Fatigue
0 1 2 3 4
26 Weight loss
0 1 2 3 4
0 1 2 3 4
27 other （
）
28 other （
）
iPLAS_version1.0
4
◆ SURGICAL REPORT　-primary surgery[1] Date of Surgery
20
m
d
[2] Operative procedure Performed
1 □ Radical hysterectomy
2 □ Semiradical hysterectomy
2
3 □ Total hysterectomy
4 □ Partial hysterectomy
[3] Surgical Stage
(FIGO stage)
1
7
y
5
6
7
□ 1A
□ 3A
□ Bilateral Salpingo-Oophorectomy
□ Unilateral Salpingo-Oophorectomy
□ Pelvic node sampling/dissection
2
8
□ 1B
□ 3B
3
9
□ 1C(
□ 3C
)(
)
4
10
8
9
88
□ Para-aortic node sampling/dissection
□ Omentectomy
□ Other, specify ( □ 2A
□4
5
□ 2B
6
□ 2C(
)(
)
)
[4] pTNM
T (
)
N (
)
[5] Percent of Gross Tumor Removed
M (
1
)
□ 100%　→[7]
2
□ Other (
%)　→[6]
[6] Greatest Diameter of Largest
Residual Gross Tumor
[7] Ascites
1 □ No
[8] Cytology of Peritoneal or Ascitic Fluids
.
2
1
cm
□ Yes
□ Negative
, Location [
2
□
Suspicious
]
3
□
Positive
4
□
Not Done
5
□
Unavailable
iPLAS_version1.0
5
PLDC Armの場合に提出していただきます
◆ PHYSICAL EXAMINATION -before administration[1] Performance Status（PS:ECOG）
□ 0 □ 1 □ 2 □ 3
[2] Weight
.
□ 4
kg
◆ LABORATORY EXAMINATION -before administration-
2 0
m
d
※ Specify individual dates when assessment dates differ
y
ANC
/mm3 3
AST/SGOT
IU/L 5
Bilirubin Total
mg/dL
2 Platelets
/mm3 4
ALT/SGPT
IU/L 6
Creatinine
mg/dL
1
◆ BIOMARKERS -before administration-
2
20
0
m
1
d
y
CA-125
U/mL
◆ DOSAGE ADMINISTRATION RECORD 【 Day 1 】
[1] Cycle delayed
1 □ Ontime
2 □ Delayed
[2] Reason for delay
(Please select 【REASON CODES】 from the following list)
( If "88=other", specify:＿ )
,
:
,
[3]Date of administration
Day1
m
d
2 0
2 0y
[5] Drug name
[6] Dose level
[7] Total dose
[8] Dose level
(mg/body)
change
(Planned dose)
[9] Reason for dose level change
(please select from 【REASON CODES】 below)
,
□ 30 mg/m
□ 25 mg/m2
2
PLD
1
mg/body
2
□ Yes→
□ No
:
,
CBDCA
□ AUC5
□ AUC4
1
mg/body
2
□ Yes→
□ No
,
(If "88=other", specify:＿)
,
(If "88=other", specify:＿)
:
【　REASON CODES　】
・ Reason for Delay
10 =ANC <1,500/mm 3
11 =PLT <100,000/mm 3
12 =AST(SGOT),ALT(SGPT) >100IU/L
13 =Bilirubin Total ≧ 1.5mg/dL
14 =Serum creatinine ≧ 1.5mg/dL
15 =Rash/Hand-foot skin reaction ≧ Grade2
16 =Mucositis oral ≧ Grade2
17 =Other adverse drug reaction ≧ Grade2 (specify: ＿ )
（ But Fatigue, Nausea, Anorexia, Alopecia ≧ Grade3 ）
88= Other (specify: ＿ )
・ Reason for Dose Level Change
20 =WBC or ANC(ongoing over 5 days) ≧ Grade4
21 =Febrile neutropenia ≧ Grade3
22 =Platelets ≧ Grade4
23= 1.5mg/dL ≦ Bilirubin Total <3.0mg/dL
(When it cannot deny causation with PLD)
24 =Rash/Hand-foot skin reaction ≧ Grade3
25 =Mucositis oral ≧ Grade3
26 =Other adverse drug reaction ≧ Grade3 (specify: ＿ )
（ Except for Fatigue, Nausea, Vomiting, Anorexia,
Hypokalemia, Hyponatremia, Lymphocyte countdecreased )
88= Other (specify: ＿ )
iPLAS_version1.0
5
GC Armの場合に提出していただきます
◆ PHYSICAL EXAMINATION -before administration[1] Performance Status（PS:ECOG）
□ 0 □ 1 □ 2 □ 3
[2] Weight
.
□ 4
kg
◆ LABORATORY EXAMINATION -before administration-
2 0
m
d
※ Specify individual dates when assessment dates differ
y
ANC
/mm3 3
AST/SGOT
IU/L 5
Bilirubin Total
mg/dL
2 Platelets
/mm3 4
ALT/SGPT
IU/L 6
Creatinine
mg/dL
1
◆ BIOMARKERS -before administration-
2
0
20
m
1
d
y
CA-125
U/mL
◆ DOSAGE ADMINISTRATION RECORD 【 Day 1 】
[1] Cycle delayed
1 □ Ontime
2 □ Delayed
[2] Reason for delay
(Please select 【REASON CODES】 from the following list)
( If "88=other", specify:＿ )
,
:
,
[3]Date of administration
Day1
m
d
2 0
2 0y
[5] Drug name
[6] Dose level
[7] Total dose
[8] Dose level
(mg/body)
change
(Planned dose)
[9] Reason for dose level change
(please select from 【REASON CODES】 below)
,
□ 1000 mg/m
□ 800 mg/m2
2
GEM
1
mg/body
2
□ Yes→
□ No
:
,
CBDCA
□ AUC4
□ AUC3
1
mg/body
2
□ Yes→
□ No
,
(If "88=other", specify:＿)
,
(If "88=other", specify:＿)
:
【　REASON CODES　】
・ Reason for Delay
10 =ANC <1,500/mm 3
11 =PLT <100,000/mm 3
12 =AST(SGOT),ALT(SGPT) >100IU/L
13 =Bilirubin Total ≧ 1.5mg/dL
14 =Serum creatinine ≧ 1.5mg/dL
17 =Other adverse drug reaction ≧ Grade2 (specify: ＿ )
（ But Fatigue, Nausea, Anorexia, Alopecia ≧ Grade3 ）
88= Other (specify: ＿ )
・ Reason for Dose Level Change
20 =Skip of Day8 in previous cycle
21 =Delay of greater than 1 but ≦ 2 weeks
22 =WBC or ANC(ongoing over 5 days) ≧ Grade4
23 =Febrile neutropenia ≧ Grade3
24 =Platelets ≧ Grade4
25= 1.5mg/dL ≦ Bilirubin Total <3.0mg/dL
(When it cannot deny causation with GEM)
26 =Other adverse drug reaction ≧ Grade3 (specify: ＿ )
（ Except for Fatigue, Nausea, Vomiting, Anorexia,
Hypokalemia, Hyponatremia, Lymphocyte countdecreased )
88= Other (specify: ＿ )
iPLAS_version1.0
6
GC Armの場合に提出していただきます
◆ LABORATORY EXAMINATION -before administration-
2 0
m
d
※ Specify individual dates when assessment dates differ
y
ANC
/mm3 3
AST/SGOT
IU/L 5
Bilirubin Total
mg/dL
2 Platelets
/mm3 4
ALT/SGPT
IU/L 6
Creatinine
mg/dL
1
◆ DOSAGE ADMINISTRATION RECORD 【 Day 8 】
[1]Date of administration
2 0
Day8
m
[2] Drug name
d
or 1□skipped ( →skip to the item[7])
y
[3] Dose level
[4] Total dose
[5] Dose level
(mg/body)
change
(Planned dose)
[6] Reason for dose level change
(please select from 【REASON CODES】 below)
,
GEM
□
□
□
□
2
1000 mg/m
800 mg/m2
500 mg/m2
400 mg/m2
1
mg/body
2
□ Yes→
□ No
,
(If "88=other", specify:＿)
:
[7] Reason for Skip
(please select from 【REASON CODES】 below)
,
:
,
(If "88=other", specify:＿)
【　REASON CODES　】
・ Reason for Skip
30 =ANC<1,000/mm3
31 =PLT<75,000/mm3
32 =AST(SGOT),ALT(SGPT) >100IU/L
33 =Bilirubin Total ≧ 1.5mg/dL
34 =Serum creatinine ≧ 1.5mg/dL
35 =Other adverse drug reaction ≧ Grade2 (specify: ＿ )
（ But Fatigue, Nausea, Anorexia, Alopecia ≧ Grade3 ）
88 =Other (specify: ＿ )
・ Reason for Dose Level Change
27 =1000/mm3 ≦ ANC< 1500/mm3
28 =75,000/mm3 ≦ PLT< 100,000/mm3
88= Other (specify: ＿ )
iPLAS_version1.0
7
◆ ADVERSE EVENTS
Please record all Adverse Events occurred each cycle of the study therapy.
・Use Common Terminology Criteria (CTCAE Version.4)
・Report the highest grade
[1] Cycle Number
[2]
No.
CTC Term
[3] Highest
（CTCAE Version.4）
grade
[4] Relationshi [5]
p to study
treatment
Additional Information
(e.g., lab values, associated dates )
1 WBC↓
0 1 2 3 4
□Yes □No Nadir:[
2 ANC↓
0 1 2 3 4
□Yes □No Nadir:[
3 Platelets↓
0 1 2 3 4
□Yes □No Nadir:[
4 Bilirubin↑
0 1 2 3 4
□Yes □No
5 AST/SGOT↑
0 1 2 3 4
□Yes □No
6 ALT/SGPT↑
0 1 2 3 4
□Yes □No
7 Albumin↓
0 1 2 3 4
□Yes □No
8 Creatinine↑
0 1 2 3 4
□Yes □No
9 Na↓
0 1 2 3 4
□Yes □No
10 K↓
0 1 2 3 4
□Yes □No
11 Anemia
0 1 2 3 4
□Yes □No
12 Allergic reaction
13 Anorexia
0 1 2 3 4
□Yes □No
0 1 2 3 4
□Yes □No
14 Nausea
0 1 2 3 4
□Yes □No
15 Vomiting
0 1 2 3 4
□Yes □No
16 Constipation
0 1 2 3 4
□Yes □No
17 Diarrhea
0 1 2 3 4
□Yes □No
18 Mucositis oral
0 1 2 3 4
□Yes □No
19 Rash/Hand-foot skin reaction
0 1 2 3 4
□Yes □No
20 Peripheral motor neuropathy
0 1 2 3 4
□Yes □No
21 Peripheral sensory neuropathy
0 1 2 3 4
□Yes □No
22 Fever
0 1 2 3 4
□Yes □No
23 Febrile neutropenia
0 1 2 3 4
□Yes □No
24 Alopecia
0 1 2 3 4
□Yes □No
25 Fatigue
0 1 2 3 4
□Yes □No
26 Weight loss
0 1 2 3 4
□Yes □No
27 other （
）
0 1 2 3 4
□Yes □No
28 other （
）
0 1 2 3 4
□Yes □No
]mm 3 Date:
/
/ 20
3
]mm Date:
/
/ 20
]mm Date:
/
/ 20
3
◆ SUPPORTIVE CARE
[6] Did hospitalization occur as a result of the toxicities above?
1
□ No
2
□ Yes, Specify:
[7] Was a transfusion administered at this course of therapy?
1
□ No
2
□ Yes → □ RCC
units
□ PC
units
□ FFP
units
□ Other
units
[8] Were cytokines administered this course?
1
□ No
2
□ Yes → □ G-CSF
□ Other
iPLAS_version1.0
8
◆ TARGET LESION(S) EVALUATION
[2] Site of lesion
[3] Date of evaluation
m
d
[4] Method**( If other, specify:＿)
[5] Diameter
y
20
20
20
20
20
1.
2.
3.
4.
5.
** Method of evaluation:
1 = Clinical examination 2 = Spiral CT scan 3 = CT scan
4 = Chest X-ray
5 = MRI
6 = Ultrasound
7 = PET
:
mm
:
mm
:
mm
:
mm
:
mm
[6] Sum of diameters
of all target lesions
88 = Other
mm
（specify:＿）
◆ NON-TARGET LESION(S) EVALUATION
[2] Site of lesion
[3] Date of evaluation
m
d
[4] Method**( If other, specify:＿) [5] Follow-up status
y
20
20
20
20
20
1.
2.
3.
4.
5.
20
:
1□CR　3□Non-CR/Non
PD　4□PD　5□NE
:
1□CR　3□Non-CR/Non
PD　4□PD　5□NE
:
1□CR　3□Non-CR/Non
PD　4□PD　5□NE
:
1□CR　3□Non-CR/Non
PD　4□PD　5□NE
:
1□CR　3□Non-CR/Non
PD　4□PD　5□NE
↓◆ NEW LESION(S)/◆ TUMOR RESPONSEはサイクル中および追跡時に入力していただきます。
◆ NEW LESION(S)
[1] New lesions since the baseline evaluation? 1 □ No
2 □ Yes, specify below:
[2] Site of lesion
[3] Date of evaluation
[4] Method**( If other, specify:＿ )
m
d
y
20
1.
:
◆ TUMOR RESPONSE
[1] Evaluation of TARGET lesion
[2] Evaluation of NON-TARGET lesion
[3] Overall response
1 □ CR
2 □ PR
1
1
3
□ CR
□ CR
□ SD
3
□ PR 3 □ SD 4 □ PD
□ Non-CR/Non-PD 4 □ PD
4
□ PD
2
88
88
88
□ NE
□ NE
□ NE
22 0
iPLAS_version1.0
9
◆ END OF STUDY
[1] Did the patient complete the protocol defined treatment?
1
□ Yes → Skip to ◆BEST TUMOR RESPONSE
2
□ No → Specify below ( [2-1]-[2-2] )
[2-1] The date of study off
20
m
d
y
[2-2] Primary reason for study off ( select one )
20
□ Disease progression, relapse during
2 0active treatment
□ Adverse events ( Please select primary reason↓ )
□ Over 2-week delay ⇒ (
□ANC
□PLT
20
20
□AST(SGOT),ALT(SGPT)
□Other
2 0 →[2-3] )
□Serum creatinine
□Bilirubin Total
□ Over 4-week delay ( □Rash/Hand-foot skin
reaction　□Mucositis oral　）
20
□ Necessity of reduction at the lowest dose level
□Platelets
⇒ (
□WBC
□ANC
□Febrile neutropenia
□Bilirubin Total
□Rash/Hand-foot skin reaction □Mucositis oral
□ Grade4 non-hematologic toxicities
□ Bilirubin Total ≧3.0g/dL
□ LVEF≦50% after administration
□ Other →[2-3]
□
□
□
□
□Other →[2-3] )
Patient withdrawal or refusal for toxicity reason
Patient withdrawal or refusal for reason other than toxicity
Death
Other →[2-3]
[2-3] Specify the reason :
◆ BEST TUMOR RESPONSE
20
[1] Best tumor response
1
□ CR
2
□ PR
3
□ SD
4
□ PD
88
□ NE
20
◆ TOXICITY ASSESSMENT
2 □ Yes, specify below ↓
□ No
Additional Information
(e.g., lab values, associated dates[mm/dd/yyyy])
Any protocol treatment-related toxicities(≧Grade2) present at the end of study?
No.
[1]
CTC Term
(CTCAE Version.4)
[2] CTCAE
grade
1
2 ・ 3 ・ 4
2
2 ・ 3 ・ 4
3
2 ・ 3 ・ 4
[3]
1
20
iPLAS_version1.0
10
◆ VITAL STATUS
[1] Patient's vital status
1
□ Alive
2
□ Dead
3
[2] Last contact date / Death date
□ Unknown
20
m
d
y
[3] Primary cause of death
1
3
□ Due to this disease
□ Unknown
2
4
□ Related to protocol treatment
□ Due to other cause,specify:
20
◆ NOTICE OF PROGRESSION
[1] First diagnose of a progression after the protocol treatment?
(If progression or recurrence has been previously reported, check the "NOT APPLICABLE" box.)
1
□ No
2
□ Yes
20
3
□ NOT APPLICABLE (Previously reported)
2 0 / recurrence
[2] Date of progression
[1] にて"No/Yes"を選択した場合、Form8を提出していただきます。
m
d
2 02 0 y
◆ NON-PROTOCOL THERAPY
[1] Is the patient receiving any non-protocol therapy not previously reported?
1 □ No
2 □ Yes, Specify below↓
[2] Name of non-protocol therapy
20
20
[3] Start date (MM/DD/YYYY)
20
20
20
20
2 0 2 02 0
20
20
2200 2 0
20
iPLAS_version1.0

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