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Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy (Esostrate)

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ClinicalTrials.gov Identifier: NCT02551458
Recruitment Status : Terminated (sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.)
First Posted : September 16, 2015
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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Brief Summary:

Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.

The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.

Evaluation of the response 5 to 6 weeks after the RCT.

Step 2: Randomisation in patients with a complete clinical response:

Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence

Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).


Condition or disease Intervention/treatment Phase
Epidermoid Carcinoma or Adenocarcinoma of the Thoracic Oesophagus or Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II) Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 Other: Systematic surgery Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Official Title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY
Actual Study Start Date : March 14, 2016
Actual Primary Completion Date : March 15, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Systematic surgery Other: Systematic surgery
Experimental: Arm B: Surveillance and rescue surgery in cases of resectable Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of surviving patients [ Time Frame: 1 year after randomisation ]
  2. Disease-free survival [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Epidermoid carcinoma (EC) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (Siewert type I or II) proven histologically
  • Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 after a full investigation
  • Patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting
  • Age ≥ 18 years < 75 years
  • Patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies.

Exclusion Criteria:

  • Cancer of the cervical oesophagus (15 to 19 cm from the dental arches)
  • Weight loss > 15% at the recruitment with no improvement after nutritional support
  • Serious comorbidity threatening survival in the short term
  • Contra-indication for radiochemotherapy
  • Other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers)
  • Absence of effective contraception in patients (men or women) able to procreate, pregnant or breast-feeding women
  • Impossibility to follow the trial
  • Legal disqualification (patients in custody or under guardianship)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551458


Locations
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Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02551458    
Other Study ID Numbers: Bedenne PHRC N 2013
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell