Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)

26 augustus 2017 bijgewerkt door: Sung-Bae Kim, Asan Medical Center

A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus

To investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy.

Studie Overzicht

Toestand

Beëindigd

Interventie / Behandeling

Gedetailleerde beschrijving

After completion of concurrent chemoradiotherapy, patients will be reassed and visited to multidisciplinary clinic, then, randomized to either observation or esophagectomy.

Studietype

Ingrijpend

Inschrijving (Verwacht)

486

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Histologically proven squamous cell carcinoma of the intrathoracic esophagus
  2. Surgically resectable (cT3, cT4a and/or disease with lymph node metastasis by AJCC 7th ed) esophageal cancer, as determined by Endoscopic Ultra Sound (EUS), chest CT and PET-CT
  3. No prior treatment for the esophageal cancer
  4. Age: 20-70 years
  5. ECOG performance status 0, 1 or 2
  6. Adequate hematological, renal, hepatic, pulmonary and cardiac functions defined as 6.1 Granulocytes > 1,500/microliter, Platelets > 75,000/microliter 6.2 Creatinine < 1.5 mg/dL (or CCr> 50 mg/mL), 6.3 Total bilirubin < 1.5 mg/dL 6.4 ALT and AST < 2.5 × upper normal limit 6.5 FEV1 >=1.5 L/min 6.6 Ejection fraction >= 45%
  7. Non-pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
  8. Written, voluntary informed consent

Exclusion Criteria:

  1. Subtypes other than squamous cell carcinoma
  2. cT1N0M0, cT2N0M0 esophageal cancer or in situ carcinoma
  3. Invasion of recurrent laryngeal, phrenic or sympathetic nerve
  4. Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
  5. Invasion of major vessels (vena cava, azygos vein and aorta) by the tumor
  6. Malignant pleural effusion (documented by cytospin or cytology)
  7. Cervical esophageal cancer
  8. Para-aortic lymph node metastasis
  9. Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, curatively treated carcinoma in situ of the cervix, curatively treated early gastric cancer with endoscopic mucosal resection or a cured malignancy more than 5 years prior to enrollment
  10. Previous chemotherapy or prior history of radiotherapy interfering with the planned radiotherapy as per protocol
  11. Patients with a known history of HIV seropositivity or HCV (+). Patients with HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
  12. Other serious illness or medical conditions A. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection (viral, bacterial or fungal infection) D. Other serious medical illnesses
  13. New York heart Association Class III/IV and history of active angina. Documented myocardial infarction within the 6 months preceding registration. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks.
  14. Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
  15. Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  16. Uncontrolled diabetes mellitus: fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control; fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Arm B: observation:
No additional treatment after concurrent chemoradiotherapy. However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
Experimenteel: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
slokdarmresectie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
2-year disease-free survival (DFS) rate
Tijdsspanne: 2 years from the enrollment of last patient
2 years from the enrollment of last patient

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Overall survival (OS)
Tijdsspanne: 5 years from the enrollment of last patient
5 years from the enrollment of last patient
progression-free survival
Tijdsspanne: 5 years from the enrollment of last patient
5 years from the enrollment of last patient
failure pattern
Tijdsspanne: 5 years from the enrollment of last patient
5 years from the enrollment of last patient
Number of Participants with Adverse Events
Tijdsspanne: up to 60 days after treatment
up to 60 days after treatment
Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy
Tijdsspanne: 5 years
5 years
Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Comparison of OS according to metabolic response after induction chemotherapy
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Quality of life
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Comparison of PFS according to metabolic response after induction chemotherapy
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Comparison of TTF according to metabolic response after induction chemotherapy
Tijdsspanne: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
treatment-related mortality
Tijdsspanne: up to 60 days after completion of treatment
up to 60 days after completion of treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2012

Primaire voltooiing (Werkelijk)

1 januari 2017

Studie voltooiing (Werkelijk)

1 januari 2017

Studieregistratiedata

Eerst ingediend

27 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

30 november 2012

Eerst geplaatst (Schatting)

4 december 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 augustus 2017

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2017

Laatst geverifieerd

1 augustus 2017

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren