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Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)

26 août 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Anticipé)

486

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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;

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Arm B: observation:
No additional treatment after concurrent chemoradiotherapy. However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
Expérimental: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
oesophagectomie

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
2-year disease-free survival (DFS) rate
Délai: 2 years from the enrollment of last patient
2 years from the enrollment of last patient

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2012

Achèvement primaire (Réel)

1 janvier 2017

Achèvement de l'étude (Réel)

1 janvier 2017

Dates d'inscription aux études

Première soumission

27 novembre 2012

Première soumission répondant aux critères de contrôle qualité

30 novembre 2012

Première publication (Estimation)

4 décembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2017

Dernière vérification

1 août 2017

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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