Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer
A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the activity of gefitinib, in terms of median survival and distant metastatic disease control, in patients treated with neoadjuvant and adjuvant cisplatin, fluorouracil, and radiotherapy who are undergoing surgery for esophageal and gastroesophageal junction cancer.
Secondary
- Determine the pathologic complete and partial response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients and in patients who are disease free and receiving long-term maintenance gefitinib.
OUTLINE:
- Preoperative regimen: Patients undergo radiotherapy twice a day during days 1-12 (for a total of 10 treatment days). Patients receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4. Patients also receive oral gefitinib once daily on days 1-28. At 6 weeks, patients with locoregionally confined disease undergo surgical resection and then proceed to the postoperative regimen. Patients with a medical contraindication to surgery proceed directly to the postoperative regimen.
- Postoperative regimen: Beginning 4-10 weeks after surgery or 6 weeks after completing the first course of therapy, patients undergo radiotherapy and receive fluorouracil and cisplatin as in the preoperative regimen.
- Maintenance regimen: Patients receive oral gefitinib beginning on day 1 of the postoperative regimen and continuing for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 80 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
-
-
Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
-
-
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:
Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction
- T3, N1, or M1a disease only
The following types are not allowed:
- Small cell undifferentiated carcinomas, lymphomas, or sarcomas
- Small cell or mixed small cell/non-small cell histology
- No evidence of distant hematogenous tumor metastases (M1b)
- No malignant pleural effusions
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC > 3,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Alkaline phosphatase < 2 times normal
- AST < 2 times normal
- No unstable or uncompensated hepatic disease
Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium normal
- No unstable or uncompensated renal disease
Cardiovascular
- No unstable or uncontrolled angina
- No unstable or uncompensated cardiac disease
Pulmonary
- See Disease Characteristics
- No limitations to pulmonary function that would preclude study participation
- No evidence of clinically active interstitial lung disease (asymptomatic patients with chronic stable radiographic changes are allowed)
- No unstable or uncompensated respiratory disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No evidence of severe or uncontrolled systemic disease
- No other uncontrolled malignancy
- No active infection
- No known severe hypersensitivity to gefitinib or any of its excipients
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy for this cancer
Chemotherapy
- No prior chemotherapy for this cancer
Radiotherapy
- No prior radiotherapy for this cancer
Surgery
- Recovered from any prior oncologic or other major surgery
- No prior surgical resection for this cancer
- No concurrent ophthalmic surgery
Other
- No prior photodynamic therapy for this cancer (prior laser treatments are acceptable)
- More than 30 days since prior unapproved or investigational drug
- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
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:非ランダム化
- 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)
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 |
---|---|---|
Survival at 1 year
時間枠:1 year
|
Survival at 1 year
|
1 year
|
Distant metastatic control at 1 year
時間枠:1 year
|
Distant metastatic control at 1 year
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Response rate at 6 weeks
時間枠:6 weeks
|
Response rate at 6 weeks
|
6 weeks
|
Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks
時間枠:6 weeks
|
Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks
|
6 weeks
|
Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy
時間枠:8 weeks
|
Toxicity of maintenance gefitinib as measured by CTC version 2.0
|
8 weeks
|
協力者と研究者
捜査官
- スタディチェア:David J. Adelstein, MD、Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (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
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
- CCF5848
- P30CA043703 (米国 NIH グラント/契約)
- CCF-5848 (その他の識別子:Cleveland Clinic IRB)
- ZENECA-1839/US/0233
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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