Comparison of Systematic Surgery Versus Surveillance and... | NCT02551458

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

NCT02551458

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Terminated

Last Update Posted

Mar 7, 2024Actual

Enrollment

188Actual

Phase

Phase 2Phase 3

Conditions

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

Interventions

Systematic surgery
Surveillance and rescue surgery in cases of resectable loco-regional recurrence

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.

Expanded Access Info

Start Date

Mar 14, 2016Actual

Primary Completion Date

Mar 15, 2023Actual

Completion Date

Not provided

First Submitted Date

Aug 20, 2015

First Submission Date that Met QC Criteria

Sep 14, 2015

First Posted Date

Sep 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Description Module

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)).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Systematic surgery	Experimental		Other: Systematic surgery
Arm B: Surveillance and rescue surgery in cases of resectable	Experimental		Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systematic surgery	Other		Arm A: Systematic surgery
Surveillance and rescue surgery in cases of resectable loco-regional recurrence

Measure	Description	Time Frame
Proportion of surviving patients		1 year after randomisation
Disease-free survival		Up to 5 years

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens		Amiens		80054	France
Centre d'oncologie et de radiothérapie du Pays Basque

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018307	Neoplasms, Squamous Cell