Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma
2016年11月8日 更新者：Hai-Qiang Mai,MD,PhD、Sun Yat-sen University
A Randomized Phase II Non-inferiority Study of Two Cycles Versus Three Cycles of Cisplatin Based Concurrent Chemoradiotherapy for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma Based on Pretreatment Plasma EBV DNA Level
This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.
調査の概要
詳細な説明
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia.
Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC.
Concurrently, although cisplatin-based concurrent chemoradiotherapy was considered as the standard regimen for locoregionally advanced nasopharyngeal carcinoma, several prospective randomized trials have demonstrated that only 52-63% patients can finished three cycles cisplatin-based concurrent chemoradiotherapy( DDP, 100mg/m2,D1,D22 and D43), due to chemoradiotherapy induced toxicity.
Combined analyses of NPC-9901 and NPC-9902 Trials indicated that the 5-year locoregional failure free survival was insignificant between the patients received between two and three cycles cisplatin-based concurrent chemoradiotherapy.
Our previous studies have also demonstrated that the five years overall survival, distant metastasis free survival and 5-year locoregional failure free survival was not observed significant difference between the patients received between two and three cycles cisplatin-based concurrent chemotherapy.
It indicated that one pressing questions remain to be resolved: can we define the optimal dose so that we can reduce toxicity by avoiding unnecessary overdose or an ineffective phase of treatment?
Recently, the quantification of pretreatment plasma Epstein-Barr virus (EBV) DNA, which was considered the most potential biomarker to compliment TNM stage, was demonstrated a useful biomarker for the risk stratification, monitoring and prediction of the prognosis of NPC.
The investigators previous study demonstrated that for local and regionally advanced NPC patients with EBV DNA <4,000copies/mL, the 3-year's PFS and DMFS was approximate to 90%.
Pretreatment plasma EBV DNA levels might be applied to guide concurrent chemotherapy regimen for local and regionally advanced NPC patients.
Therefore, the investigators make a hypothesis that the low risk locoregionally advanced NPC patients received two cycles of chemotherapy may gain similar long-term survival as those received three cycles of chemotherapy, leading to less chemotherapy induced toxicity.
Therefore, this phase II non-inferiority, randomised controlled clinical trial was designed to assess efficacy for low-risk patients, identified with pretreatment plasma EBV DNA <4,000 copies/mL, received two cycle cisplatin-based chemotherapy compared with three cycle cisplatin-based chemotherapy
研究の種類
介入
入学 (予想される)
236
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lin-Quan Tang, MD,PHD
- 電話番号：8602087343643
- メール：tanglq@sysucc.org.cn
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510060
- 募集
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
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コンタクト：
- Haiqiang Mai, MD,Ph.D
- 電話番号：86-20-8734-3643
- メール：maihq@mail.sysu.edu.cn
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Original clinical staged as T3-4N0-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）
- No evidence of distant metastasis (M0)
- Pretreatment Plasm EB Virus DNA<4000copies/ml
- Male and no pregnant female
- Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
- With normal renal function test (Creatinine ≤ 1.5×ULN)
Exclusion Criteria:
- Patients have evidence of relapse or distant metastasis
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- Receiving radiotherapy or chemotherapy previously
- The presence of uncontrolled life-threatening illness
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Receiving other ways of anti-cancer therapy.
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
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実験的：Two cycle CCRT
Concurrent cisplatin(100mg/m2,D1,D22)combine with IMRT
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Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT
他の名前：
Concurrent cisplatin (100mg/m2，D1,D22 and D43) combine with IMRT
他の名前：
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アクティブコンパレータ：Three cycle CCRT
Concurrent cisplatin(100mg/m2,D1,D22 and D43)combine with IMRT
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Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT
他の名前：
Concurrent cisplatin (100mg/m2，D1,D22 and D43) combine with IMRT
他の名前：
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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 |
|---|---|---|
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Progress-free survival
時間枠：3 years
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Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
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3 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The shor-term toxic effects
時間枠：3 months
|
The shorterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
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3 months
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Complete Response (CR)
時間枠：after the completion of the chemoradiotherapy treatment (up to 9 weeks)
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CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Disease response evaluated after the completion of the chemoradiotherapy treatment.
Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only
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after the completion of the chemoradiotherapy treatment (up to 9 weeks)
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Overall Survival(OS)
時間枠：3 years
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The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up
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3 years
|
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Locoregional Relapse-Free Survival(LRRFS)
時間枠：3 years
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The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
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3 years
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Distant Metastasis-Free Survival (DMFS)
時間枠：3 years
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The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit
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3 years
|
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Cost-effectiveness analysis
時間枠：3 years
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The cost (including direct cost drug fees, inspection fees, expenses and nursing cost) and incremental cost-effectiveness ratio was calculated between two arms
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3 years
|
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The monitoring of plasma EBV DNA
時間枠：3 years
|
The plasma EBV DNA will be detected before treatment ,during treatment (weekly) and during follow up( every 3-6 months)
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3 years
|
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Long-term toxicities
時間枠：3 years
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Patients will be monitored for long-term toxicity by standard NIH criteria.
QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck
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3 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年8月1日
一次修了 (予想される)
2018年7月1日
研究の完了 (予想される)
2021年7月1日
試験登録日
最初に提出
2016年7月17日
QC基準を満たした最初の提出物
2016年8月17日
最初の投稿 (見積もり)
2016年8月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月10日
QC基準を満たした最後の更新が送信されました
2016年11月8日
最終確認日
2016年11月1日
詳しくは
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