低リスクの HPV 関連中咽頭扁平上皮がん患者における段階的緩和放射線療法 (EVADER)
低リスクHPV関連中咽頭扁平上皮癌患者における選択的容積調整減圧放射線療法（EVADER）の第II相単群試験
The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.
調査の概要
詳細な説明
The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy.
These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.
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
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British Columbia
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Prince George、British Columbia、カナダ、V2M 7E9
- BCCA - Centre for the North
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Vancouver、British Columbia、カナダ、V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg、Manitoba、カナダ、R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、カナダ、A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Ontario
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Hamilton、Ontario、カナダ、L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston、Ontario、カナダ、K7L 2V7
- Kingston Health Sciences Centre
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Ottawa、Ontario、カナダ、K1H 8L6
- Ottawa Hospital Research Institute
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Toronto、Ontario、カナダ、M5G 2M9
- University Health Network
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Toronto、Ontario、カナダ、M4N 3M5
- Odette Cancer Centre
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Quebec
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Montreal、Quebec、カナダ、H4A 3J1
- The Research Institute of the McGill University
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Montreal、Quebec、カナダ、H3T 1E2
- The Jewish General Hospital
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Québec、Quebec、カナダ、G1R 2J6
- Hotel-Dieu de Quebec
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Sherbrooke、Quebec、カナダ、J1H 5N4
- CIUSSS de l'Estrie - Centre hospitalier
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Saskatchewan
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Regina、Saskatchewan、カナダ、S4T 7T1
- Allan Blair Cancer Centre
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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 with pathologically proven diagnosis of HPV-related OPSCC
- Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)
- Patients must be eligible for definitive RT or CRT
- Must be ≥ 18 years of age
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in either English or French
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient registration
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
- The following radiological investigations must be done within 8 weeks of randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue primary tumors); PET-CT scan.
- Patient must consent to provision of, and investigator(s) must confirm location and commit to obtain a representation of formalin-fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays described in Section 12 (Correlative Studies) may be conducted. Please see the Correlative Manual for details
- Patient must consent to provision of samples of blood and plasma (for circulating cell free DNA) in order that the specific correlative marker assays described may be conducted.
- Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria:
- Previous chemotherapy or radiotherapy treatment for head and neck cancer
- Patients with an unknown primary.
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 |
|---|---|
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他の：Experimental arm
This is a non-randomized, single-arm study evaluating elective volume-adjusted de-escalation radiotherapy. Patients receive one of two treatment options, based on treating physician discretion. Both options are considered part of a unified treatment strategy and analyzed as a single arm.
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 7 weeks (5 fractions/week) Cisplatin: Either 100 mg/m² on days 1, 22, and 43 or 40 mg/m² weekly for 7 weeks
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 6 weeks (6 fractions/week) |
35 fractions, 5/wk, 7 wks 70Gy/56Gy, or 35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or 35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy
他の名前：
100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
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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Event-free Survival
時間枠：2 years
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Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events:
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2 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 |
|---|---|---|
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Overall Survival
時間枠：2 years
|
For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years. |
2 years
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Local-regional Control
時間枠：2 years
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Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first:
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2 years
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Out-of-field Regional Control
時間枠：2 years
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Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years. |
2 years
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Distant Metastasis Free Survival
時間枠：2 years
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Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years. |
2 years
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協力者と研究者
捜査官
- スタディチェア：Scott Bratman、Princess Margaret Cancer Centre, Toronto, ON
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 (推定)
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
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。