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Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)

26. august 2017 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Forventet)

486

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Arm B: observation:
No additional treatment after concurrent chemoradiotherapy. However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
Eksperimentell: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
esofagektomi

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Overall survival (OS)
Tidsramme: 5 years from the enrollment of last patient
5 years from the enrollment of last patient
progression-free survival
Tidsramme: 5 years from the enrollment of last patient
5 years from the enrollment of last patient
failure pattern
Tidsramme: 5 years from the enrollment of last patient
5 years from the enrollment of last patient
Number of Participants with Adverse Events
Tidsramme: 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
Tidsramme: 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;
Tidsramme: 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
Tidsramme: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
Quality of life
Tidsramme: 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;
Tidsramme: 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;
Tidsramme: 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
Tidsramme: 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
Tidsramme: 5 years from the enrollment of the last patient
5 years from the enrollment of the last patient
treatment-related mortality
Tidsramme: up to 60 days after completion of treatment
up to 60 days after completion of treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2012

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

27. november 2012

Først innsendt som oppfylte QC-kriteriene

30. november 2012

Først lagt ut (Anslag)

4. desember 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2017

Sist bekreftet

1. august 2017

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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