標的療法を受けている転移性腎細胞癌患者における粘膜炎の有害事象を治療するための葉酸サプリメントとプラセボ (DARENCA4)
FASTERCC：標的療法を受けている転移性腎細胞癌患者における粘膜炎の有害事象を治療するための葉酸サプリメントとプラセボ。デンマークの腎がんグループによるランダム化二重盲検試験 (DARENCA Study-4)
FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)
調査の概要
詳細な説明
Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI, immunotherapy or mTOR inhibitor treatment in mRCC patients.
The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor treatment or immunotherapy and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO.
This is a randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed.
The investigators anticipate a 96-month accrual period. The power calculation indicates a total of 50 patients per group are required.
Block randomization based on received TKI/ mTOR inhibitor/IT-treatment will be performed.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Central Region of Denmark
-
Aarhus、Central Region of Denmark、デンマーク、8000
- Aarhus University Hospital, Department of oncology
-
-
Herlev
-
Herlev、Herlev、デンマーク、2730
- Department of Oncology, Herlev Hospital
-
-
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
Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.
Inclusion Criteria:
- Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.
- Signed written informed consent obtained prior to any study specific procedures.
- Patient must be willing and able to comply with the protocol.
- Age ≥ 18.
- Biopsy proven locally advanced or metastatic renal cell carcinoma.
- Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
- Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
- Karnofsky Performance status ≥ 60%.
Exclusion Criteria:
- Known hypersensitivity to folic acid.
- Use of prednisolone more than 10 mg daily.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Treatment arm
5 mg of folic acid (1 tablet) per day for 12 weeks. |
5 mg pr day for 12 weeks |
|
プラセボコンパレーター：Placebo arm
PLACEBO (1 tablet) per day for 12 weeks. |
1 placebo pill pr day for 12 weeks |
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 |
|---|---|---|
|
CTCAE Mucositis
時間枠：16 weeks
|
The degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE). |
16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PRO Mucositis frequency
時間枠：16 weeks
|
The frequency of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC. |
16 weeks
|
|
Time to effect on mucositis
時間枠：16 weeks
|
The median time to effect of study drug according to CTCAE 4.0 and PRO. |
16 weeks
|
|
Dose reductions
時間枠：16 weeks
|
The frequency of TKI/mTOR dose reductions in the two groups |
16 weeks
|
|
Treatment discontinuations
時間枠：16 weeks
|
The frequency of TKI/mTOR/immunotherapy treatment discontinuations in the two groups |
16 weeks
|
|
Treatment withdrawals
時間枠：16 weeks
|
The frequency of TKI/mTOR/immunotherapy treatment withdrawals in the two groups |
16 weeks
|
|
GI adverse events degree
時間枠：16 weeks
|
The degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
Hand-foot syndrome degree
時間枠：16 weeks
|
The degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
QOL NCCN
時間枠：16 weeks
|
The quality of life in the two groups according to NCCN-FACT FKSI-19. |
16 weeks
|
|
PRO Mucositis degree
時間枠：16 weeks
|
The degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC. |
16 weeks
|
|
GI adverse events frequency
時間枠：16 weeks
|
The frequency of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
Hand-foot syndrome frequency
時間枠：16 weeks
|
The frequency of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO. |
16 weeks
|
|
QOL MDASI
時間枠：16 weeks
|
The quality of life in the two groups according the M.D. Anderson Symptom Inventory for RCC. |
16 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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