- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00258323
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Survival at 1 year
Zeitfenster: 1 year
|
Survival at 1 year
|
1 year
|
Distant metastatic control at 1 year
Zeitfenster: 1 year
|
Distant metastatic control at 1 year
|
1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response rate at 6 weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 8 weeks
|
Toxicity of maintenance gefitinib as measured by CTC version 2.0
|
8 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: David J. Adelstein, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kopf-Hals-Neubildungen
- Erkrankungen der Speiseröhre
- Ösophagusneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Cisplatin
- Fluorouracil
Andere Studien-ID-Nummern
- CCF5848
- P30CA043703 (US NIH Stipendium/Vertrag)
- CCF-5848 (Andere Kennung: Cleveland Clinic IRB)
- ZENECA-1839/US/0233
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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