Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection
A Prospective, Multi-centric, Phase Ⅲ, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine (AG) Versus Oxaliplatin Plus Folinic Acid and Fluorouracil (OFF) for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVES:
- To evaluate the therapeutic efficacy of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection.
SECONDARY OBJECTIVES:
- To evaluate the therapeutic efficacy of two regimens in terms of objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- To evaluate the time to remission of patients treated with the two regimens.
- To evaluate the progression-free survival of patients treated with the two regimens.
- To evaluate the levels of tumor biomarkers in serum of patients treated with the two regimens, including Carbohydrate Antigen (CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP.
- To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 4.0 in patients treated with the two regimens.
- To evaluate the quality of life score of patients treated with the two regimens.
Detailed Description of Arms:
Patients are randomized to 1 of 2 treatment arms (Arm AG or Arm OFF). Arm AG: Firstly, patients receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Secondly, patients receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.
Arm OFF: Patients receive oxaliplatin 85 mg/m^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Patients receive folinic acid 200 mg/m^2 (iv) and fluorouracil 2000 mg/m^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days. Treatment repeats until there is disease progression or recurrence.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前:Xian-Jun Yu, M.D PH.D
- 電話番号:+86 21 64175590
- メール:yuxianjun@fudanpci.org
研究連絡先のバックアップ
- 名前:Wen-Quan Wang, M.D PH.D
- 電話番号:+86 21 64175590
- メール:wangwenquan@fudanpci.org
研究場所
-
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Guangdong
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Guangzhou、Guangdong、中国、510060
- 募集
- Department of Hepatobiliary Surgery, Sun Yat-Sen University Cancer Center,Sun Yat-Sen University
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コンタクト:
- Sheng-Ping Li, M.D PH.D
- 電話番号:020-87343088
- メール:lishengp@mail.sysu.edu.cn
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主任研究者:
- Sheng-Ping Li, M.D PH.D
-
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Shanghai
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Shanghai、Shanghai、中国、200032
- 募集
- Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
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Shanghai、Shanghai、中国、200003
- 募集
- Department of Biliary Pancreatic Surgery, Shanghai Changzheng Hospital, The Second Military Medical University
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コンタクト:
- Cheng-Hao Shao, M.D PH.D
- 電話番号:021-81886999
- メール:schhao88@gmail.com
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主任研究者:
- Cheng-Hao Shao, M.D PH.D
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Shanghai、Shanghai、中国、200040
- 募集
- Department of Biliary Pancreatic Surgery, Huadong Hospital, Fudan University
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コンタクト:
- Wei Wang, M.D PH.D
- 電話番号:021-62483180
- メール:wangw2003cn@hotmail.com
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主任研究者:
- Wei Wang, M.D PH.D
-
Shanghai、Shanghai、中国、200040
- 募集
- Department of Pancreatic Surgery, Huashan Hospital, Fudan University
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コンタクト:
- De-Liang Fu, M.D PH.D
- 電話番号:021-52889999
- メール:surgeonfu@163.com
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主任研究者:
- De-Liang Fu, M.D PH.D
-
-
Tianjin
-
Tianjin、Tianjin、中国、300060
- 募集
- Department of Pancreatic Surgery, Cancer Institute & Hospital, Tianjin Medical University
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コンタクト:
- Ji-Hui Hao, M.D PH.D
- 電話番号:022-23340123
- メール:haojihui@tjmuch.com
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主任研究者:
- Ji-Hui Hao, M.D PH.D
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Zhejiang
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Hangzhou、Zhejiang、中国、310016
- 募集
- Department of General Surgery,Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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コンタクト:
- Yi-Ping Mou, M.D PH.D
- 電話番号:0571-86090073
- メール:mouyp@srrsh.com
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主任研究者:
- Yi-Ping Mou, M.D PH.D
-
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) after R0 or R1 resection. The pathological staging does not exceed the stage ⅡB. And the patients have received gemcitabine as adjuvant chemotherapy after curative resection.
- There is progression or recurrence of tumor during the course of adjuvant chemotherapy with gemcitabine, or within 6 months after the whole courses of treatment.
- No severe defects in hematological system, immune system, cardiac function and pulmonary function.
- White blood cell (WBC) ≥ 4 × 10^9/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets (PLT) ≥ 100 × 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL
- Aspartate aminotransferase (AST) (serum glutamate oxaloacetate transaminase (SGOT))/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
- Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN
- The patients are willing to comply to the study plan and other requirements.
Exclusion Criteria:
- There is another malignant tumor with the patient.
- Patients who have received any form of anti-tumor therapy within 4 weeks prior to the enrollment, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
- Use of any other investigational agents within 4 weeks prior to the enrollment.
- The progression or recurrence of tumor occurs after 6 months of the course of the adjuvant chemotherapy with gemcitabine.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, internal hemorrhage, pancreatic leakage, bile leakage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to the drugs.
- Metabolic acidosis, acute or chronic, including ketoacidosis
- Pregnant or nursing women
- Any event or condition that is possible to harm the safety of the patients or the integrities of data, including severe medical risk factors, medical conditions, and laboratory disorders.
- Patients who are unwilling or unable to comply with study procedures, or may be absent from the observation for more than 7 days.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:nab-paclitaxel + gemcitabine (AG)
nab-paclitaxel at 100 mg/m^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m^2 on days 1, 8, and 15
|
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment.
Treatment repeats until there is disease progression or recurrence.
他の名前:
Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment.
Treatment repeats until there is disease progression or recurrence.
他の名前:
|
実験的:oxaliplatin + folinic acid + fluorouracil (OFF)
oxaliplatin at 85mg/m^2 on days 8 and 22, folinic acid at 200mg/m^2 on days 1,8,15 and 22, fluorouracil at 2000mg/m^2 on days 1,8,15 and 22.
|
Patients receive oxaliplatin 85 mg/m^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle.
Treatment repeats until there is disease progression or recurrence.
Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days.
Patients receive folinic acid 200 mg/m^2 (iv) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment.
Treatment repeats until there is disease progression or recurrence.
他の名前:
Patients receive fluorouracil 2000 mg/m^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment.
Treatment repeats until there is disease progression or recurrence.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall survival
時間枠:From date of enrollment until the date of death from any cause, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
To evaluate the therapeutic efficacy of second-line adjuvant therapy with AG versus OFF in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection.
Outpatient visit, phone interview
|
From date of enrollment until the date of death from any cause, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Objective Response Rate
時間枠:Complete Remission% + Partial Remission %, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
To evaluate the therapeutic efficacy of two regimens in terms of objective response rate.
Computed tomography (CT) scan
|
Complete Remission% + Partial Remission %, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
Time to Remission
時間枠:From date of enrollment until the date of remission, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
To evaluate the time to remission of patients treated with the two regimens.
Computed tomography (CT) scan
|
From date of enrollment until the date of remission, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
Progression-Free Survival
時間枠:From date of enrollment until the date of first documented progression, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
To evaluate the progression-free survival of patients treated with the two regimens.
Computed tomography (CT) scan
|
From date of enrollment until the date of first documented progression, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
The Levels of Tumor Biomarkers in Serum
時間枠:2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
To evaluate the levels of tumor biomarkers in serum of patients treated with the two regimens, including Carbohydrate Antigen (CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP .
Outpatient visit, laboratory findings
|
2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0
時間枠:1 week during therapy and 3 months thereafter up to 24 months.
|
To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0) in patients treated with the two regimens.
The toxicity profile includes but not limits neutropenia, thrombocytopenia, peripheral neuropathy, hypoglycemia, metabolic acidosis (acute or chronic, including ketoacidosis), which will be summarized as the percentage of patients by type and grade according to treatment group.
Outpatient visit, laboratory findings.
|
1 week during therapy and 3 months thereafter up to 24 months.
|
Quality of life
時間枠:2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
To evaluate the quality of life score of patients treated with the two regimens.
Outpatient visit, phone interview
|
2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Xian-Jun Yu, M.D PH.D、Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
nab-paclitaxelの臨床試験
-
EBG MedAustron GmbHLandesklinkum Wiener Neustadt募集
-
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-
Medtronic Endovascular完了
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Conor Medsystems終了しました
-
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