Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer (NeoResII)

August 26, 2025 updated by: Magnus Nilsson, Karolinska University Hospital

Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia

This study compares outcomes with regard to the timing of resective surgery after neoadjuvant chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study hypothesis is that a longer delay improves histological response and decreases the risk of postoperative morbidity and mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Department of Surgery Gastrocentrum Karolinska Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically verified adenocarcinoma or SCC of the esophagus or GEJ Siewert type I and II.
  • Tumors should be resectable and without distant metastasis, as assessed after completed CRT.
  • Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
  • Pre CRT tumor stage: T1N1-3M0, T2N0-3M0, T3N0-3,M0, T4aN0-3,M0
  • Written informed consent
  • Completed at least 80% of the planned chemotherapy and at least 90% of the prescribed radiotherapy dose within the neoadjuvant CRT schedule according to protocol within a period of <36 days.

Exclusion Criteria:

  • Concomitant malignant diagnosis (excluding non-melanoma skin cancer) <5 years since current cancer diagnosis.
  • Ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy.
  • Patients being unable to comply with the protocol for reasons of language or cognitive function.
  • Tumor stage T1N0, T4bNX or TXNXM1.
  • Carcinoma of the upper third of the esophagus (i.e. cervical and uppermost thoracic) for simplicity here defined as upper border of tumor above 22 cm from incisors at endoscopy.
  • Clear radiological signs of tumor progression during CRT on CT-scan after completion of CRT. PET is not used in this decision as FDG-activity often increase due to radiotherapy induced inflammation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resective surgery after 4-6 weeks
Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT)
Procedure: Resective surgery
Active Comparator: Resective surgery after 10-12 weeks
Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT)
Procedure: Resective surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete histological response proportion, using the Chirieac grading system.
Time Frame: analysis is completed 4 weeks after surgery
analysis is completed 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall primary tumor treatment response defined as complete histological response (Chirieac 0) and partial histological response (Chirieac 1 and 2) together.
Time Frame: analysis is completed 4 weeks after surgery
analysis is completed 4 weeks after surgery
ypN tumor status, classified as ypN0 to ypN3.
Time Frame: analysis is completed 4 weeks after surgery
analysis is completed 4 weeks after surgery
5 year survival by intention to treat and per protocol analyses in each study arm.
Time Frame: 5 years
5 years
Proportion of disease free patients after 5 years by intention to treat and per protocol analyses in each study arm.
Time Frame: 5 years
5 years
R0 resection rate in each study arm.
Time Frame: analysis is completed 4 weeks after surgery
analysis is completed 4 weeks after surgery
Resectability rate in each study arm.
Time Frame: 4-6 or 10-12 weeks after completed CRT
4-6 or 10-12 weeks after completed CRT
Safety and toxicity (only grade 3-5 toxicity will be reported) ety and toxicity (only grade 3-5 toxicity will be reported)
Time Frame: 4-6 or 10-12 weeks after completed CRT
According to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
4-6 or 10-12 weeks after completed CRT
Postoperative complications in each study arm.
Time Frame: 30 days after surgery
Using the classification in the Swedish National Registry for Gastric and Esopgageal Cancer (NREV), including Clavien-Dindo classification.
30 days after surgery
Health-related quality of life (HRQOL).
Time Frame: 4-6 or 10-12 weeks prior to surgery (at randomization after completed CRT), within a week before surgery, 6 months postoperatively, 12 months postoperatively and then yearly until 5 years of follow-up.
Validated questionnaires that assess patients functions (physical, emotional, social, role and cognitive function), symptoms (e.g. fatique, pain, nausea/vomiting, appetite, dysphagia, eating difficulties and diarrhea) and global quality of life.
4-6 or 10-12 weeks prior to surgery (at randomization after completed CRT), within a week before surgery, 6 months postoperatively, 12 months postoperatively and then yearly until 5 years of follow-up.
QUALYs at 5 year follow-up in each study arm.
Time Frame: 5 years after surgery
Quality Adjusted Life Year assesses not only how much longer the treatment will allow the patient to live, but weighs in the quality of life with survival as a composite variable.
5 years after surgery
Correlation between symptom scores, endoscopy and radiology; and complete histological response.
Time Frame: 4 weeks after surgery
4 weeks after surgery
Nutritional status of patients in each study arm.
Time Frame: within a week before the start of CRT, within a week before surgery and 5 years after surgery
within a week before the start of CRT, within a week before surgery and 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Oslo University Hospital
University Hospital of North Norway
University Hospital, Linkoeping
Lund University Hospital
University Hospital, Umeå
Region Örebro County
University Hospital Cologne
Sahlgrenska University Hospital
St. Olavs University Hospital

Investigators

  • Principal Investigator: Magnus Nilsson, Prof, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

April 19, 2019

Study Completion (Actual)

August 5, 2024

Study Registration Dates

First Submitted

February 22, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimated)

April 14, 2015

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/748-31-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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