Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2024-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

NCT01362127

Carcinoma, Squamous Cell Adenocarcinoma of the Esophagus and Gastric Cardia

COMPLETED PHASE2

Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

NCT03381651

Esophageal Carcinoma Neoadjuvant Chemoradiotherapy Surgery

COMPLETED NA

Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal Cancer

NCT03474341

Esophageal Cancer Esophageal Adenocarcinoma Esophageal Squamous Cell Carcinoma +1 more

UNKNOWN

Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma

NCT01404156

Esophageal Cancer Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction

COMPLETED PHASE2/PHASE3

Efficacy and Safety Study of the Combined Modality Therapy in Adenocarcinoma of the Esophago-gastric Junction

NCT01523015

Adenocarcinoma of the Gastroesophageal Junction

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer of the Esophagus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resective surgery after 4-6 weeks

Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT)

Group Type ACTIVE_COMPARATOR

Resective surgery

Intervention Type PROCEDURE

Resective surgery after 10-12 weeks

Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT)

Group Type ACTIVE_COMPARATOR

Resective surgery

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resective surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No