Cancer of the EsophagusNeoResIINCT02415101
Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer
A study testing Resective surgery in people with Cancer of the Esophagus, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of the Esophagus
- What is being tested?
- Resective surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Stockholm, 14186
About this study
Official title: 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.
- Conditions
- Cancer of the Esophagus
- Being tested
- Resective surgery
- Keywords
- Adenocarcinoma, Squamous cell carcinoma, Gastroesophageal Junction
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resective surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Resective surgery after 4-6 weeks | Active comparator | Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT) Receives: Procedure: Resective surgery |
| Resective surgery after 10-12 weeks | Active comparator | Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT) Receives: Procedure: Resective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histological response proportion, using the Chirieac grading system.
Measured: analysis is completed 4 weeks after surgery
Secondary outcomes (12)
Overall primary tumor treatment response defined as complete histological response (Chirieac 0) and partial histological response (Chirieac 1 and 2) together.
Measured: analysis is completed 4 weeks after surgery
ypN tumor status, classified as ypN0 to ypN3.
Measured: analysis is completed 4 weeks after surgery
5 year survival by intention to treat and per protocol analyses in each study arm.
Measured: 5 years
Proportion of disease free patients after 5 years by intention to treat and per protocol analyses in each study arm.
Measured: 5 years
R0 resection rate in each study arm.
Measured: analysis is completed 4 weeks after surgery
Resectability rate in each study arm.
Measured: 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)
According to Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Measured: 4-6 or 10-12 weeks after completed CRT
Postoperative complications in each study arm.
Using the classification in the Swedish National Registry for Gastric and Esopgageal Cancer (NREV), including Clavien-Dindo classification.
Measured: 30 days after surgery
Health-related quality of life (HRQOL).
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.
Measured: 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.
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.
Measured: 5 years after surgery
Correlation between symptom scores, endoscopy and radiology; and complete histological response.
Measured: 4 weeks after surgery
Nutritional status of patients in each study arm.
Measured: within a week before the start of CRT, within a week before surgery and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completion19 Apr 2019
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the EsophagusStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Lund University Hospital, Sahlgrenska University Hospital, Region Örebro County, University Hospital, Umeå, St. Olavs Hospital, University Hospital, Linkoeping, University Hospital of North Norway, University Hospital of Cologne
- Responsible party
- Principal investigator, Magnus Nilsson, Karolinska University Hospital
- Investigators
- Magnus Nilsson, Prof, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415101
- Sponsor's protocol ID
- 2014/748-31-3
- Acronym
- NeoResII
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2015
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nilsson K, Klevebro F, Rouvelas I, Lindblad M, Szabo E, Halldestam I, Smedh U, Wallner B, Johansson J, Johnsen G, Aahlin EK, Johannessen HO, Hjortland GO, Bartella I, Schroder W, Bruns C, Nilsson M. Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer. Ann Surg. 2020 Nov;272(5):684-689. doi: 10.1097/SLA.0000000000004340.
PubMed 32833767
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia
- ClinicalTrials.gov ID
- NCT02415101
- Acronym / sponsor ID
- NeoResII / 2014/748-31-3
- Conditions
- Cancer of the Esophagus
- Keywords
- Adenocarcinoma, Squamous cell carcinoma, Gastroesophageal Junction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Lund University Hospital, Sahlgrenska University Hospital, Region Örebro County, University Hospital, Umeå, St. Olavs Hospital, University Hospital, Linkoeping, University Hospital of North Norway, University Hospital of Cologne
- Study start
- Feb 2015 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resective surgery after 4-6 weeks | Active comparator | Procedure: Resective surgeryResective surgery 4-6 weeks after completed chemoradiotherapy (CRT) |
| Resective surgery after 10-12 weeks | Active comparator | Procedure: Resective surgeryResective surgery 10-12 weeks after completed chemoradiotherapy (CRT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resective surgery | Procedure or surgery | Resective surgery after 10-12 weeks, Resective surgery after 4-6 weeks |
Primary outcome
Complete histological response proportion, using the Chirieac grading system.
Time frame: analysis is completed 4 weeks after surgery
12 secondary outcomes
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
ypN tumor status, classified as ypN0 to ypN3.
Time frame: 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
Proportion of disease free patients after 5 years by intention to treat and per protocol analyses in each study arm.
Time frame: 5 years
R0 resection rate in each study arm.
Time frame: analysis is completed 4 weeks after surgery
Resectability rate in each study arm.
Time frame: 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
Postoperative complications in each study arm.
Time frame: 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.
QUALYs at 5 year follow-up in each study arm.
Time frame: 5 years after surgery
Correlation between symptom scores, endoscopy and radiology; and complete histological response.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Derived from this study: PubMed 32833767Nilsson K, Klevebro F, Rouvelas I, Lindblad M, Szabo E, Halldestam I, Smedh U, Wallner B, Johansson J, Johnsen G, Aahlin EK, Johannessen HO, Hjortland GO, Bartella I, Schroder W, Bruns C, Nilsson M. Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer. Ann Surg. 2020 Nov;272(5):684-689. doi: 10.1097/SLA.0000000000004340.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Nilsson, Prof principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resective surgery in people with Cancer of the Esophagus, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete histological response proportion, using the Chirieac grading system. (time frame: analysis is completed 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.