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Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)

26 augusti 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Förväntat)

486

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2012

Primärt slutförande (Faktisk)

1 januari 2017

Avslutad studie (Faktisk)

1 januari 2017

Studieregistreringsdatum

Först inskickad

27 november 2012

Först inskickad som uppfyllde QC-kriterierna

30 november 2012

Första postat (Uppskatta)

4 december 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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