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Does waiting longer for surgery after chemoradiation improve esophageal cancer outcomes?

NCT ID NCT02415101

Knowledge-focused Sponsor: Karolinska University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether waiting 10-12 weeks instead of the usual 4-6 weeks after chemoradiation before surgery helps patients with esophageal or gastric cardia cancer. 202 participants were randomly assigned to one of the two timing groups. The goal was to see if a longer delay leads to a better tumor response and fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
resective surgery
What this could lead to
If a longer wait improves tumor response and reduces complications, it could lead to better surgical outcomes for esophageal cancer patients.
What could go wrong
This is a completed study comparing two timing schedules, not a new treatment. The results may not change standard practice if no clear benefit is found.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

202 people

The number who actually took part.

Started

Feb 2015

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma carcinoma of esophagus esophageal cancer Esophageal Neoplasms gastric cardia carcinoma squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer of the esophagus

Contacts and locations

Locations

  • Department of Surgery Gastrocentrum Karolinska Univeristy Hospital

    Stockholm, 14186, Sweden

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