Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)
A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Forventet)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Seoul, Korea, Republikken, 05505
- Asan Medical Center
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the intrathoracic esophagus
- 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
- No prior treatment for the esophageal cancer
- Age: 20-70 years
- ECOG performance status 0, 1 or 2
- 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%
- Non-pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
- Written, voluntary informed consent
Exclusion Criteria:
- Subtypes other than squamous cell carcinoma
- cT1N0M0, cT2N0M0 esophageal cancer or in situ carcinoma
- Invasion of recurrent laryngeal, phrenic or sympathetic nerve
- Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
- Invasion of major vessels (vena cava, azygos vein and aorta) by the tumor
- Malignant pleural effusion (documented by cytospin or cytology)
- Cervical esophageal cancer
- Para-aortic lymph node metastasis
- 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
- Previous chemotherapy or prior history of radiotherapy interfering with the planned radiotherapy as per protocol
- 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.
- 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
- 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.
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- 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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Ingen indgriben: Arm B: observation:
No additional treatment after concurrent chemoradiotherapy.
However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
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Eksperimentel: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
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esofagektomi
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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2-year disease-free survival (DFS) rate
Tidsramme: 2 years from the enrollment of last patient
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2 years from the enrollment of last patient
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Overall survival (OS)
Tidsramme: 5 years from the enrollment of last patient
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5 years from the enrollment of last patient
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progression-free survival
Tidsramme: 5 years from the enrollment of last patient
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5 years from the enrollment of last patient
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failure pattern
Tidsramme: 5 years from the enrollment of last patient
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5 years from the enrollment of last patient
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Number of Participants with Adverse Events
Tidsramme: up to 60 days after treatment
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up to 60 days after treatment
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Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy
Tidsramme: 5 years
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5 years
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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
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5 years from the enrollment of the last patient
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Comparison of OS according to metabolic response after induction chemotherapy
Tidsramme: 5 years from the enrollment of the last patient
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5 years from the enrollment of the last patient
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Quality of life
Tidsramme: 5 years from the enrollment of the last patient
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5 years from the enrollment of the last patient
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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
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5 years from the enrollment of the last patient
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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
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5 years from the enrollment of the last patient
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Comparison of PFS according to metabolic response after induction chemotherapy
Tidsramme: 5 years from the enrollment of the last patient
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5 years from the enrollment of the last patient
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Comparison of TTF according to metabolic response after induction chemotherapy
Tidsramme: 5 years from the enrollment of the last patient
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5 years from the enrollment of the last patient
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treatment-related mortality
Tidsramme: up to 60 days after completion of treatment
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up to 60 days after completion of treatment
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Neoplasmer, pladecelle
- Esophageale neoplasmer
- Karcinom
- Karcinom, pladecelle
- Esophageal pladecellekarcinom
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- Esophageal cancer AMC02
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