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

• ClinicalTrials.gov Identifier: NCT02551458
• Recruitment Status: Recruiting
• First Posted: September 16, 2015
• Last Update Posted: September 16, 2015
• Sponsor: Centre Hospitalier Universitaire Dijon
• Information provided by (Responsible Party): Centre Hospitalier Universitaire Dijon

Tracking Information

• First Submitted Date: August 20, 2015
• First Posted Date: September 16, 2015
• Last Update Posted Date: September 16, 2015
• Study Start Date: Not Provided
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 14, 2015)

• Proportion of surviving patients [ Time Frame: 1 year after randomisation ]
• Disease-free survival [ Time Frame: Up to 5 years ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
• Official Title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY

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
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Not Provided

Condition

• 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

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Laurent BEDENNE; 3 80 38 13 14 ext +33; laurent.bedenne@u-bourgogne.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02551458
• Other Study ID Numbers: Bedenne PHRC N 2013
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Hospitalier Universitaire Dijon
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire Dijon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire Dijon
• Verification Date: March 2015