A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients
A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
- To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
- To evaluate the toxicities of the two treatment methods.
調査の概要
詳細な説明
The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups, but disease free survival was prolonged in the maintenance arm and not in the induction arm. Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm. Many trials, designed several years ago, delivered single agent chemotherapy and were not particularly intensive. Most clinical trials were dealing with a heterogenous group of head and neck cancer patients. We felt that a better choice of adjuvant chemotherapy on cancers should include: (1) localized cancers with high metastatic potential following effective local treatment; (2) effective chemotherapy available; (3) chemotherapy should be intensive and effective enough to avoid the development of drug resistance. Of course, NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized, advanced staged disease.
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate, decreasing the metastatic rate and local recurrence rate, then many NPC patients may benefit.
Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients.
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Taipei、台湾、112
- Veterans General Hospital-Taipei
-
-
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:
- Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
- Original stage must be stage IV disease (M0)
- Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
- Performance status scale ECOG grade 0,1.
- Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance > 45ml/min if Creatinine > 1.5mg/dl.
- Patients must be younger than 70 year-old.
- Patients must give signed informed consent.
Exclusion Criteria:
- Patients had progressive disease after radiotherapy
- Patients had evidence of distant metastasis.
- Patients had completed radiotherapy for more than 7 weeks.
- The presence of life-threatening illness
- History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
- Previous chemotherapy.
- Pregnancy.
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)
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 |
---|
overall survival, relapse free survival,distant metastasis and local-regional control rates.
|
二次結果の測定
結果測定 |
---|
toxicities of the two treatment methods.
|
協力者と研究者
協力者
捜査官
- 主任研究者:Kwan-Hwa Chi, MD,、Taiwan cooperative oncology group
研究記録日
主要日程の研究
研究開始
研究の完了
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。
Cisplatin,5-FU,Leucovorinの臨床試験
-
Hamamatsu University完了
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Glaxo Wellcome完了
-
University Medical Center GroningenAmsterdam UMC, location VUmc完了
-
Ralf HofheinzInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest; Deutsche Krebshilfe... と他の協力者募集
-
Sol-Gel Technologies, Ltd.完了
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.わからない