Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer
Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- Determine the complete pathologic response (complete response [CR]) rate in patients with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine, and radiotherapy.
Secondary
- Determine the clinical efficacy and toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
- Identify basal expression and changes in gene expression that relate to CR, relapse, and survival of patients treated with this regimen.
OUTLINE:
- Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 (weeks 1, 3, and 5). Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 and receive oral or enteral capecitabine twice daily on the same days they undergo radiotherapy.
- Surgery: At 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients who are eligible undergo esophagectomy.
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and oral or enteral capecitabine twice daily on days 1-5, 8-12, 15-19, 22-26, and 29. Treatment repeats approximately every 14 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene expression studies, microarray analysis, and real-time quantitative reverse transcriptase-PCR to identify basal expression and changes in gene expression.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
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
-
-
New York
-
Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
-
-
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
DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus
- Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound
- Bulk of gastroesophageal junction tumor should be in the esophagus
- Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 4 months
- WBC > 4,000/mm³
- ANC > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9 g/dL
- Bilirubin normal
- Creatinine normal
- AST < 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Able to take oral medication or undergo enteral administration of medication
- No peripheral neuropathy ≥ grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 90 days after completion of study treatment
- No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy
No concurrent uncontrolled illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would preclude study compliance
No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- Other cured tumors allowed at discretion of the principal investigator
- No known HIV or hepatitis B or C (active and/or previously treated)
PRIOR CONCURRENT THERAPY:
- No prior therapy for esophageal cancer
- No other concurrent investigational agents
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:Chemo
Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29.
Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly).
Capecitabine will be continued until the final dose of radiotherapy
|
相関研究
Correlative Study
Ⅳ
オーラル
Correlative Study
Correlative Study
Metastatic growth control
Examination of tissue type
Tissue removal
Tumor shrinkage
Undergoing radiation therapy
|
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 |
時間枠 |
---|---|
Complete Response
時間枠:5.5 weeks
|
5.5 weeks
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1
時間枠:5.5 weeks
|
5.5 weeks
|
Median Time to Progression
時間枠:5.5 weeks
|
5.5 weeks
|
Quality of Life Improved Rate
時間枠:5.5 weeks
|
5.5 weeks
|
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 (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 (見積もり)
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。
食道がんの臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
遺伝子発現解析の臨床試験
-
Foundation for Innovative New Diagnostics, SwitzerlandUniversity of Witwatersrand, South Africa; PD Hinduja Hospital and Medical Research Centre,... と他の協力者完了
-
The Center for the Biology of Chronic Disease完了エプスタイン-バーウイルス感染症 | サイトメガロウイルス感染症 | ヒトパピローマウイルス | 単純ヘルペス感染症 | 水痘帯状疱疹ウイルス感染症アメリカ
-
University of BaselNational Cancer Center, Korea; University Hospital, Geneva; Swiss National Science Foundation; University... と他の協力者募集
-
Shire完了
-
University of North Carolina, Chapel HillCenters for Disease Control and Prevention完了
-
National Institute for Medical Research, TanzaniaUniversity of Kinshasa (UNIKIN), Congo, The Democratic Republic of the ( Prof Vivi Maketa); Research... と他の協力者まだ募集していませんCOVID-19(新型コロナウイルス感染症)
-
Michigan State University募集敗血症 | 全身性炎症反応症候群 | 感染症、細菌 | 感染症、コロナウイルス | 感染症、真菌 | 混合感染アメリカ
-
Hvidovre University HospitalElsassFonden終了しました