Study of a Predictor for Cervix Cancer (ANOXICOL)
Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade I to IIIB Cervix Carcinoma Treated by Radiotherapy
Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.
Persistence of tumor hypoxia could be a predictive factor of local control
調査の概要
詳細な説明
HPV linked cervix cancer is the second most prevalent form of female cancer. It's also the leading cause of death by cancer in Asia, South America and Africa. Hopefully, screening program lead to a 50 % of mortality reduction during the past 40 years. Classic therapeutic strategy consists of external pelvic radiation therapy associated with chemotherapy and followed by brachytherapy. Curative surgical removal is realized 4 to 6 weeks after radiation therapy. However relapse rate is frequent (20 to 30%). Biological mechanisms involved in this high relapse rate are not understood.
Nevertheless, it is suggest that initial hypoxia of cervix tumor during 20 Gy radiation therapy is a pejorative prognostic factor. At the opposite, the amelioration of tumor vascularisation during 20 Gy radiation therapy is a positive prognostic factor. It's possible that an amelioration of hypoxia lead to lesser tumor resistance to radiotherapy. However such possibility has to be test during clinical trial.
Thus, the objective of ANOXICOL study is to evaluate the predictive value of persistent hypoxia, during 20 Gy radiation therapy associated with chemotherapy, for local control of cervix cancer.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Lille、フランス、59020
- Oscar Lambret Center
-
-
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:
- cervix epidermoid cancer or adenocarcinoma : I to IIIB
- treatment by radiochemotherapy
- ECOG ≤ 1
- social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
- patient affiliated to health insurance system
- signed informed consent
Exclusion Criteria :
- contraindication to chemoradiotherapy
- resequable cervical cancer
- para-aortic metastases histologically proven
- inability to perform an abdominal MRI or a PET Scan
- contraindications related to MRI: pacemaker, vascular clip, and all devices incompatible with the electromagnetic field generated by MRI
- unbalanced diabete
- administration of EPO
- transfusion within 3 days before the first biopsy
- creatinine clearance under 60 mL / min;
- ANC <1500 / mm3 and Platelets <120,000 / mm3
- neuropathy, diabetes (fasting glucose greater than 140 mg / l) or any other condition that strongly contraindicates concomitant chemotherapy with radiotherapy
- sigmoid diverticulitis, Crohn's disease or systemic disease, collagenose
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：他の
- 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 |
|---|---|
|
実験的：local control 19.8Gy
local control at 19.8 Gy, at Day 14
|
Day 14, full body TEP and pelvis MRI
|
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 |
|---|---|---|
|
change from baseline of value of persisting hypoxia at day 14
時間枠：Baseline, Day 14
|
dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
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Baseline, Day 14
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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 |
|---|---|---|
|
safety
時間枠：baseline, Day 14, Day 45, Day 120
|
NCI CTCAE v 4.0
|
baseline, Day 14, Day 45, Day 120
|
|
MRI and TEP local control evaluation
時間枠：4 months
|
4 months
|
|
|
impact of tumor hypoxia on necrosis appearance
時間枠：Day 45 and Day 120
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necrosis quantification from biopsies
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Day 45 and Day 120
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|
correlation between biomarkers of tumor hypoxia evolution and local control
時間枠：baseline, Day 14, Day 45 and Day 120
|
evaluate necrosis appearance as a proxy to local control
|
baseline, Day 14, Day 45 and Day 120
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nickers Philippe, MD、Centre Oscar Lambret
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 (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
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。
子宮頸がんの臨床試験
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