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Patient Background Form ( Form B )
◆ DISEASE INFORMATION
No → Fill in [5] Criteria for Progressive Disease of CA-125.
[5] Criteria for Progressive Disease of CA-125 ＊ Please refer 3.2 "Progression criteria of CA-125" on page 4 in the protocol.
◆ CANCER THERAPY FOR OVARIAN CANCER
Yes → Fill in SURGICAL REPORT on Form S.
◆ NON-INVASIVE DIAGNOSTIC PROCEDURES -within 28 days before patient registration-
◆ MEDICAL HISTORY
[1] Previous or current diseases other than primary cancer Surgical Form ( Form S )
◆ SURGICAL REPORT
・Please record the detail of cytoreductive surgery.
◆ COMMENTS
Pre-Treatment Summary Form ( Form P )
◆ BASELINE FINDINGS
Please record the current abnormal physical findings before administration.
23 Stomatitis (Please select WHO Grade) 28 other (　　　　　　　　　　　　　　　　) 29 other (　　　　　　　　　　　　　　　　) 30 other (　　　　　　　　　　　　　　　　) ※ Please record "other" colum if any abnormal physical findings before administration of Doxil
Pre-Treatment Summary Form ( Form P )
◆ TARGET LESION(S) EVALUATION -within 28 days before administration-
※ Please record this item only ◆DISEASE INFORMATION [4] Measurable or Non-Measurable lesion is "Yes" on B Form.
[4] Method**( If other, specify:＿ ) [5] Longest diameter ◆ NON-TARGET LESION(S) EVALUATION -within 28 days before administration-
※ Please record this item only ◆DISEASE INFORMATION [4] Measurable or Non-Measurable lesion is "Yes" on B Form.
◆ BIOMARKERS
※ Please record this item only ◆DISEASE INFORMATION [4] Measurable or Non-Measurable lesion is "No" on B Form.
Drug Dose Form ( Form D )
Cycle Number
◆ PHYSICAL EXAMINATION -before administration-
◆ BIOMARKERS
◆ DOSAGE ADMINISTRATION RECORD
[3] Reason for delay (select from 【REASON CODES】 on CD Form) [8] Reason for Dose Level Change [9] Dosing Rate (select from 【REASON CODES】 on CD Form) ◆ PREMEDICATION FOR RASH/HAND-FOOT SKIN REACTION
Dexamethasone
Drug Dose Form ( Form D )
Cycle Number
◆ PHYSICAL EXAMINATION -before administration-
◆ BIOMARKERS
◆ INCEPTION CRITERIA
※ Please check Table4. "inception criteria" on page 12 in the protocol.
※ Specify individual dates when assessment dates differ.
×104/mm3 4 (clinical exam and functional/symptomatic) ◆ DOSAGE ADMINISTRATION RECORD
[3] Reason for delay (select from 【REASON CODES】 on CD Form) [8] Reason for Dose Level Change [9] Dosing Rate (select from 【REASON CODES】 on CD Form) ◆ PREMEDICATION FOR RASH/HAND-FOOT SKIN REACTION
Dexamethasone
Drug Dose Form ( Form D )
Cycle Number
◆ PHYSICAL EXAMINATION -before administration-
◆ BIOMARKERS
◆ INCEPTION CRITERIA
※ Please check Table4. "inception criteria" on page 12 in the protocol.
※ Specify individual dates when assessment dates differ.
×104/mm3 4 (clinical exam and functional/symptomatic) ◆ NON-INVASIVE DIAGNOSTIC PROCEDURES
◆ DOSAGE ADMINISTRATION RECORD
[3] Reason for delay (select from 【REASON CODES】 on CD Form) [8] Reason for Dose Level Change [9] Dosing Rate (select from 【REASON CODES】 on CD Form) ◆ PREMEDICATION FOR RASH/HAND-FOOT SKIN REACTION
Dexamethasone
Drug Dose Form ( Form D )
Cycle Number
◆ PHYSICAL EXAMINATION -before administration-
◆ BIOMARKERS
◆ INCEPTION CRITERIA
※ Please check Table4. "inception criteria" on page 12 in the protocol.
※ Specify individual dates when assessment dates differ.
×104/mm3 4 (clinical exam and functional/symptomatic) ◆ DOSAGE ADMINISTRATION RECORD
[3] Reason for delay (select from 【REASON CODES】 on CD Form) [8] Reason for Dose Level Change [9] Dosing Rate (select from 【REASON CODES】 on CD Form) ◆ PREMEDICATION FOR RASH/HAND-FOOT SKIN REACTION
Dexamethasone
Toxicity Form ( Form T )
Cycle Number
◆ ADVERSE EVENTS
・Please record all Adverse Events occurred and highest Grade during the current cycle.
(e.g. lab values, associated dates[mm/dd/yyyy]) 23 Stomatitis (Please select WHO Grade) 28 other (　　　　　　　　　　　　　　　) 29 other (　　　　　　　　　　　　　　　) 30 other (　　　　　　　　　　　　　　　) [5] Did infusion reaction occure during the current cycle ? [7] Treatment for infusion reaction (select from 【TREATMENT CODES】 on CD Form) Code of Drug Dose Form & Toxicity Form ( Form CD )
DOXIL 【 REASON CODES 】
・ Reason for Delay
[ Recovered within 2 weeks after the scheduled Day1 of next cycle ]
10 =ANC ＜ 1,500/mm3 ( ≧ Grade2)
11 =PLT ＜ 75,000/mm3( ≧ Grade2)
12 =Non-hematologic toxicities ≧ Grade2
(except for Fatigue, Nausea, Vomiting, Anorexia) [ Recovered within 4 weeks after the scheduled Day1 of next cycle ]
13 =Rash/Hand-foot skin reaction ≧ Grade2
14 =Stomatitis ≧ Grade2
[ Other ]
88 =Other (specify: ＿ )
・ Reason for Dose Level Change
20= Rash/Hand-foot skin reaction ＝ Grade3
21 =Stomatitis (CTCAE ： clinical exam or functional/symptomatic) ≧ Grade3
22 =ANC or WBC Grade4 persisting ≧ 7 days
23 =ANC ≧ Grade3 and Fever(axilla) ≧ 38.0 ℃
24= PLT ≧ Grade3
25 =Total Bilirubin 1.5mg/dL ≦ and ＜ 3mg/dL
26 =Adverse drug reaction ＝ Grade3
(except for Fatigue, Nausea, Vomiting, Anorexia, Hypokalemia, Hyponatremia) 88 =Other (specify: ＿ )
DOXIL 【 TREATMENT CODES 】
・ Treatment for Infusion Reaction
30 =Administration of anti-allergic drug
31 =Administration of steroid drug
32 =Administration of vasopressor
33 =Oxygen inhalation
34 =Continuation of Doxil (Dosing Rate = 1mg/minute)
35 =Discontinuation and change dosing rate of Doxil
88 =Other (specify: ＿ )
Supportive Care Form ( Form SC )
Cycle Number
◆ SUPPORTIVE CARE FOR RASH/HAND-FOOT SKIN REACTION
[1] Cooling of limb during administration of Doxil Oral Vitamine B6
Dexamethasone
◆ SUPPORTIVE CARE FOR STOMATITIS
[3] Frequency of gargle (During this cycle) Aznol gargle liquid
[7] Frequency of gargle (During this cycle) Xylocaine Aznol
gargle liquid
◆ POINTS TO REMEMBER OF DAILY LIFE
[1] Did patient follow the "POINTS TO REMEMBER OF DAILY LIFE"? Rash/Hand-Foot → □ Always (75%≦ Frequency ≦100%)
→ □ Always (75%≦ Frequency ≦100%) Stomatitis
skin reaction
Solid Tumor Evaluation Form ( Form E )
◆ TIME OF EVALUATION
◆ TARGET LESION(S) EVALUATION
[4] Method**( If other, specify:＿ ) [5] Longest diameter 1 = Clinical examination 2 = Spiral CT scan 3 = CT scan ◆ NON-TARGET LESION(S) EVALUATION
[4] Method**( If other, specify:＿ ) [5] Follow-up status ◆ NEW LESION(S)
[1] New lesions since the baseline evaluation? ◆ TUMOR RESPONSE
◆ COMMENTS
Treatment Completion Form ( Form C )
◆ END OF STUDY
[1] Did the patient complete the protocol defined 4 cycles treatment? No → Specify below ( [2] Reason of study off ) [2-1] Primary reason for study off ( select one ) Disease progression or appear new lesion during active treatment Adverse events ( Please select any relevant reasons ↓ ) 21 □ Over 2-week delay (Please select any relevant events) ⇒ 　 □ANC　 □PLT　 □Non-hematologic toxicities (except for Fatigue, Nasea, Vomiting, Anorexia) 22 □ Over 4-week delay (Please select any relevant events) ⇒ 　 □Rash/Hand-foot skin reaction　 □Stomatitis 23 □ Over more than 2 times dose reduction □ANC or WBC Grade4 persisting ≧7 days 　 □ANC ≧ Grade3 and Fever(axilla) ≧38.0℃ (except for Fatigue, Nausea, Vomiting, Anorexia, Hypokalemia, Hyponatremia) 26 □ LVEF ≦50% after administration of Doxil 27 □ LVEF (before registration) ≧20% reduction Patient withdrawal or refusal for toxicity reason → specify below [2-2] Patient withdrawal or refusal for reason other than toxicity → specify below [2-2] Death → specify below [2-2] (Death date, Primary cause of death) ◆ BEST TUMOR RESPONSE
◆ COMMENTS
Follow-Up Form ( Form Q )
◆ ADVERSE EVENTS
Any protocol treatment-related toxicities(≧Grade2) present at 8 weeks after the end of study or before a non-protocol therapy start? (e.g. lab values, associated dates[mm/dd/yyyy])

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