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

Karolinska University Hospital

Status

Completed

Conditions

Cancer of the Esophagus

Treatments

Procedure: Resective surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02415101

2014/748-31-3

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.