Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas (PROPAC)
Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.
Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).
However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.
In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).
It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.
調査の概要
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
-
-
-
Marseille、フランス、13009
- Institut Paoli Calmettes
-
-
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:
- Patient aged > 18 ans and ≤ 75 ans
- Suspicion of adenocarcinoma of the head of the pancreas leading to the placement of a biliary stent
- Either metastatic or "borderline" (at the limit of resectability) or locally advanced
- PS = 0 or 1
- Hematological laboratory parameters (ANC ≥ 1.5 ** 10 9 / l (/ mm3), platelets ≥ 100 ** 10 9 / l (G / L)) and kidney (calculated creatinin clearance> 60 ml / min)
- Jaundice (bilirubin> 20 mmol / L) by compressing the lower part of the bile duct (dilatation of the extrahepatic bile duct)
- Written informed Consent
- Affiliation to social security
Exclusion Criteria:
- Pregnant or lactating woman or without contraception (for child bearing potential women)
- Patient deprived of liberty or under supervision of a guardian
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
- Contra-indication for study procedure
- Predictable technical impossibility to position a stent endoscopically (prior upper GI surgery)
- Life expectancy assumed less than 3 months
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
他の：First attempt stenting (T0 = date of the first act)
Efficacy of laying of a biliary stent for chemotherapy realization
|
Laying of a stent biliary
|
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 |
時間枠 |
|---|---|
|
Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX.
時間枠：At day 28 after the laying of the biliary stent
|
At day 28 after the laying of the biliary stent
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Rate of biliary infection starting within 3 months after insertion of the prosthesis
時間枠：From the laying of the biliary stent to 3 months follow up
|
From the laying of the biliary stent to 3 months follow up
|
|
Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)
時間枠：From the laying of the biliary stent to 3 months follow up
|
From the laying of the biliary stent to 3 months follow up
|
|
Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.
時間枠：From the laying of the biliary stent to 3 months follow up
|
From the laying of the biliary stent to 3 months follow up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jean-Luc RAOUL, MD, PHD、Institut Paoli-Calmettes
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
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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PROPAC-IPC 2012 006
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。
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