頭頸部がんにおける術後併用化学放射線療法中の生存に対する経口免疫調節栄養素の有効性 (SIMPA01)
頭頸部扁平上皮癌（HNSCC）における術後併用化学放射線療法中の生存に対する経口免疫調節栄養素の有効性を評価する二重盲検多施設第III相試験
The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.
調査の概要
状態
条件
詳細な説明
The primary objective is to evaluate the efficacy on disease-free survival of a formula enriched with L-arginine, omega-3 fatty acids, and ribonucleic acids, taken for 5 days before each cycle of chemotherapy, in patients with high-risk locally-advanced HNSCC treated with postoperative concomitant chemoradiotherapy (CRT).
This study is a national, multicentric double blinded, randomised phase III trial. A total of 306 patients (102 patients in group control vs 204 patients in group Oral Impact®) will be required including 10% of lost-to-follow-up patients.
An immunomodulating oral supplementation compound (Oral Impact®) is compared to an isocaloric isonitrogenous control. The compound to be assessed contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3. The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients. Each patient has to take Oral Impact® or a sip feed control during 5 days before each cycle of chemotherapy.
DFS will be measured from the time of randomization to the time of the first evidence of progression (local, regional, metastatic, or second primary) or death from any cause. Patients alive without carcinologic event were censored at last follow-up date.
Patients treated with postoperative CRT are expected to have a 2-year DFS rate of 60% without specific diet (pControl).
Including a ratio 1:2, an expected recruitment of 90 patients per year, the current study will require 131 events to detect an absolute improvement of 15% (HR=0.56, pExperimental=75%) with 0.90 statistical power using a two-sided test and a significance level of 0.05.
A total of 306 patients (102 vs 204) will be required including 10% of lost of follow-up patients.
The inclusion period would be 4 years, for an expected total duration of study about 8 years.
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
-
-
-
Lyon、フランス、69373
- Centre Léon Bérard
-
Montpellier、フランス、34298
- Institut du Cancer de Montpellier
-
-
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:
- Surgically resected primary squamous cell carcinomas (HNSCC) of the hypopharynx, oropharynx, larynx and oral cavity with pathological stage pT1-2 pN+ (pathological stage 1 ou 2 with node) or pT3-4 any pN (pathological stage 3 ou 4 with or without node) (UICC 7th edition, 2010),
- Postoperative concomitant CRT based on radiotherapy and on cisplatinum, 3 cycles, 100mg/m² by cycle,
- Patients who undergone macroscopically complete resection,
- High-risk characteristics patients with one or more following criteria: such as invasion of two or more regional lymph nodes, extracapsular extension of nodal disease or microscopically-involved mucosal margins of resection, perineural involvement, vascular tumor embolism,
- WHO (World Health Organization) performance status 0, 1 or 2,
- Age: 18 years old up to 75 years old including,
Exclusion Criteria:
- Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- Sepsis at baseline
- Distant metastasis
- Other immunomodulating diets in the last month before inclusion
- Parenteral nutrition at baseline
- History of hypersensitivity and/or allergy to any component of Oral Impact ®
- Patients with history of malignancies who are not disease-free for more than 5 years.
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 |
|---|---|
|
実験的：Immunomodulating oral supplementation
The immunomodulating oral supplementation compound (Oral Impact®) contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3. Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle. |
Per os administration, 3 times / day, 5 days before each cycle of chemotherapy. |
|
アクティブコンパレータ：Sip feed control
The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients: it is an isocaloric isonitrogenous control. Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle. |
Per os administration, 3 times / day, 5 days before each cycle of chemotherapy. |
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 |
|---|---|---|
|
Disease-Free Survival (DFS)
時間枠：From date of randomization until the date of the first documented progression (local, regional, metastatic) or date of death from any cause, whichever came first, assessed up to 2 years.
|
2-years DFS rate |
From date of randomization until the date of the first documented progression (local, regional, metastatic) or date of death from any cause, whichever came first, assessed up to 2 years.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：From date of randomization until the date of death from any cause, assessed up to 3 years.
|
OS at 1, 2 and 3 years |
From date of randomization until the date of death from any cause, assessed up to 3 years.
|
|
Rate of drug compliance
時間枠：up to 45 days
|
the compliance is defined as the taking of more than 75 % of study product prescription |
up to 45 days
|
|
Adverse events rate
時間枠：until 3 months after radiotherapy
|
graded based on NCI-CTCAE v4.03 |
until 3 months after radiotherapy
|
|
Quality of life by using the general quality of life questionnaire about cancer (QLQ-C30).
時間枠：Quality of life will be assessed up to 2 years after the last day of radiotherapy.
|
The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome. |
Quality of life will be assessed up to 2 years after the last day of radiotherapy.
|
|
Quality of life by using the specific quality of life questionnaire about head and neck cancer (HN35)
時間枠：Quality of life will be assessed up to 2 years after the last day of radiotherapy.
|
The EORTC HN35 uses a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. |
Quality of life will be assessed up to 2 years after the last day of radiotherapy.
|
|
Cachexia
時間枠：Cachexia will be assessed up to 3 years after the last day of radiotherapy.
|
Cachexia will be evaluated with weight (in kilograms) |
Cachexia will be assessed up to 3 years after the last day of radiotherapy.
|
協力者と研究者
捜査官
- スタディチェア：Pierre SENESSE, MD、Institut du Cancer de Montpellier - Val d'Aurelle
出版物と役立つリンク
一般刊行物
- De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.
- Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
- Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
- Machon C, Thezenas S, Dupuy AM, Assenat E, Michel F, Mas E, Senesse P, Cristol JP. Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients. Support Care Cancer. 2012 Dec;20(12):3129-35. doi: 10.1007/s00520-012-1444-5. Epub 2012 Mar 28.
- Vasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20.
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
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
- ICM-URC 2017/21
- GORTEC 2017-02 (レジストリ識別子：GORTEC)
- 2018-A00518-47 (レジストリ識別子：ID-RCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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