高齢者のHPV関連中咽頭がんにおける用量調節化学放射線療法 ((DACHOC-E))
高齢者のHPV関連中咽頭がんにおける用量調節化学放射線療法のパイロット実現可能性試験（DACHOC-E）
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.
For this reason this study is looking at a different regimen of reducing the intensity of the treatment.
The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.
調査の概要
詳細な説明
There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.
Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.
Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Regulatory Office
- 電話番号：904-202-7300
- メール：RegBMDA@bmcjax.com
研究連絡先のバックアップ
- 名前：Clinical Trials Office
- メール：clinicaltrialsdivision@bmcjax.com
研究場所
-
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Florida
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Jacksonville、Florida、アメリカ、32207
- 募集
- Baptist MD Anderson Cancer Center
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コンタクト：
- Clinical Trials and Translational Medicine Divsion
- メール：clinicaltrialsdivision@bmcjax.com
-
-
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:
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- P16-positive based on local site immunohistochemical tissue staining
- Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
- Age ≥ 65.
- Normal organ and marrow function within 14 days prior to registration defined as follows:
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
- AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
- Serum creatinine ≤ 1.5× ULN
Exclusion Criteria:
- Metastatic disease
- Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
- Synchronous double primaries
- Prior radiotherapy for lymphoma or other malignancy
- Prior systemic therapy including immunotherapy
- Severe active comorbidity where life expectancy is <1 year.
- Autoimmune disease
- Uncontrolled HIV
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 |
|---|---|
|
実験的：Experimental
Cisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment. Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study. 55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week |
Instead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach. |
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 |
|---|---|---|
|
Two-year progression free survival
時間枠：2 years
|
Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx. |
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Benefit and Tolerance of Treatment
時間枠：2 years
|
Frailty index G8 score 14 as major determinant of benefit and tolerance to treatment through: Per prior study score <14 (1-17) is an indicator of frailty. The frailty as a factor in completing therapy (yes or no) and number of days break from therapy will be used as a variable. G20 frailty index (G-20 is the actual name and not abbreviation) is as follows: A Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties? B Weight loss during the last 3 months C Mobility D Neuropsychological problems E Body Mass Index (BMI (weight in kg) / (height in m²) F Takes more than 3 medications per day G In comparison with other people of the same age, how does the patient consider his/her health status? H Age |
2 years
|
|
Acute Toxicity
時間枠：2 years
|
Acute toxicity (Grade 3 or higher) |
2 years
|
|
Late toxicity
時間枠：2 years
|
Late toxicity (Grade 3 or higher) |
2 years
|
|
Failure pattern
時間枠：2 years
|
Pattern failure (local in field, local marginal miss, local regional failure, distant failure, combination of the above). As some of the patient may have recurrence in the radiation fields, this will be termed local recurrence. Recurrence outside the radiation fields but in the head and neck area will be quantified as regional failure. Failure outside the head and neck area will be classified as distant failure. This outcome will be quantified as global number of failure out of the 20 patients and their distribution will be quantified in a diagram as explain above. |
2 years
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
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。