Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
A standard treatment for patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine to be used in combination with capecitabine.
In this research study, the investigators are looking to determine if proton or photon beam radiation in combination with hydroxychloroquine and capecitabine is effective in controlling your cancer growth.
調査の概要
詳細な説明
Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally, daily until the day before surgery and will resume after surgery until study end.
Capecitabine will be taken orally, daily. Proton or photon radiation treatment will start on Week 2 and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation treatment will be give on an outpatient basis at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at Massachusetts General Hospital.
The following tests will be performed weekly: physical exam, routine blood tests, optional blood tests and an eye exam every 3 months while taking hydroxychloroquine.
Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include: physical exam, routine blood tests, eye exam, and tumor assessment by chest and abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years 3-5).
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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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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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:
- Cytologic or histologic proof of pancreatic ductal carcinoma
- Life expectancy > 3 months
- Adequate organ and marrow function
Exclusion Criteria:
- Evidence of metastatic disease
- Pregnant or breast-feeding
- Tumors in the body or tail of the pancreas
- Serious concomitant systemic disorders such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifest by fever
- Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
- Diagnosis of other invasive carcinomas (except basal cell carcinomas/squamous cell carcinoma of the skin) with the last 5 years. Carcinoma in-situ is allowed.
- Other serious uncontrolled medical conditions
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Known, existing uncontrolled coagulopathy
- Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier). Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD deficiency
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
- History of uncontrolled seizures, central nervous system disorders, or psychiatric disability
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- Currently taking cimetidine
- Receiving any other study agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine and HCQ
- Already taking HCQ or chloroquine for other diagnosis
- History of Grade 3 or greater retinopathy or keratitis
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：Hydroxychloroquine
Hydroxychloroquine with chemoradiation
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825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
他の名前：
400 mg BID from study day 1 until surgery.
Dosing resumed upon discharge from hospital
他の名前：
Daily, beginning Week 2 for 5 consecutive days
|
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 |
|---|---|---|
|
Progression-free survival
時間枠：2 years
|
To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, chemoradiation therapy and adjuvant gemcitabine chemotherapy
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathologic response rate
時間枠：2 years
|
To determine the complete pathologic response rate of preoperative capecitabine combined with hydroxychloroquine and short course radiation therapy in patients undergoing pancreaticoduodenectomy
|
2 years
|
|
Overall survival
時間枠：2 years
|
To determine overall survival in patients treated with preoperative capecitabine + hydroxychloroquine and short course radiation therapy
|
2 years
|
|
Toxicity/Adverse events
時間枠：2 years
|
To determine the toxicity of capecitabine + hydroxychloroquine and short course radiation therapy in patients with pancreatic cancer via analysis of frequency and grades of reported toxicities and adverse events, such as GI and hematologic toxicities, occurring in study participants
|
2 years
|
|
Surgical morbidity
時間枠：2 years
|
To determine the surgical morbidity in patients undergoing pancreaticoduodenectomy who received preoperative capecitabine + hydroxychloroquine and external beam radiation therapy
|
2 years
|
|
Post-operative Mortality
時間枠：2 weeks
|
To determine 30-day post-operative mortality after pancreaticoduodenectomy in patients who receive preoperative capecitabine and external beam radiation therapy
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2 weeks
|
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Biomarkers
時間枠：2 years
|
To explore biomarkers of autophagy with hydroxychloroquine therapy and explore correlation with progression-free survival
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2 years
|
|
Pathologic down-staging
時間枠：2 years
|
To determine pathologic down-staging of hydroxychloroquine-based short course chemoradiation compared to a previous cohort (treated in prior study of neoadjuvant capecitabine + proton therapy)
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2 years
|
|
Local control
時間枠：2 years
|
To determine local tumor control at 2 years post treatment in study participants
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2 years
|
|
Describe QoL
時間枠：2 Years
|
To describe quality of life, symptom burden and mood in the study population
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2 Years
|
|
Measure utilization of health services
時間枠：2 years
|
Measure utilization of health services (ER, hospital and ICU visits) in the study population
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2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
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