NCT02415101Completed
Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer
Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 202 (actual)
- First submitted
- 22 Feb 2015
- Start date
- 1 Feb 2015
- Primary completion date
- 19 Apr 2019
- Lead sponsor
- Karolinska University Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02415101
What you commit to
- Study type: Interventional
- Participants enrolled: 202
- From 1 Feb 2015 to the primary completion date, 19 Apr 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant malignant diagnosis (excluding non-melanoma skin cancer) \<5 years since current cancer diagnosis.
- 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.
Other illness
- Ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Surgery Gastrocentrum Karolinska Univeristy Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.