Thromboprophylaxis in Oesophageal Cancer Patients

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-05-01

Brief Summary

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

The purpose of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.

Related Clinical Trials

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

Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

NCT00022139

Esophageal Cancer Gastric Cancer

COMPLETED PHASE2

Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer

NCT00054873

Esophageal Neoplasms Stomach Neoplasms Adenocarcinoma

COMPLETED PHASE2

Positron Emission Tomography in Determining Stage of Esophageal Cancer

NCT00004867

Esophageal Cancer

COMPLETED NA

Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy

NCT04554771

Esophageal Adenocarcinoma Oesophageal Adenocarcinoma Resectable Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer

NCT02954536

Esophageal Cancer Gastric Cancer

COMPLETED PHASE2

Detailed Description

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

Hypotheses

1. The intervention group of oesophageal cancer patients, who receive prolonged thromboprophylaxis with Fragmin® has a lower VTE risk, expressed by a lower prothrombin fragment F1+2, 30 days after surgery than the control group, who receive Fragmin® for 10 days.
2. The intervention group does not demonstrate an increased bleeding tendency compared with the control group.

Primary endpoint The primary endpoint is the difference in prothrombin fragment F1+2 30 days after surgery between the intervention and the control group.

Secondary and safety endpoints The secondary endpoints are incidence of bleeding, VTE and mortality 30 days and one year after surgery.

Study design

The study is comprised of three specific objectives, presented in three work packages (WP):

* WP1: Randomization of 100 oesophageal cancer patients undergoing intended curative surgery to either a 10 or 30-day prophylactic LMWH-regime.
* WP2: Investigation of the coagulation in the WP1 population. The aim is to substantially improve understanding of the coagulation pathophysiology and the mechanisms behind the increased thromboembolic risk in oesophageal cancer patients.
* WP3: The lectin pathway complement proteins are suspected to play a role in the increased risk of thrombosis in cancer. We aim to examine this further by measuring complement protein levels in the WP1 population and investigate if there is a correlation between complement levels and changes in the coagulation.

Conditions

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

Esophageal Neoplasms Thrombosis Thromboembolism

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

Randomized, controlled trial with one intervention group and one control group.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

No masking due to ethical considerations. Primary outcome is biochemical.

Study Groups

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

Intervention

Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily.

Group Type EXPERIMENTAL

Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

Intervention Type DRUG

30 days postoperative prophylactic treatment.

Control

Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily.

Group Type ACTIVE_COMPARATOR

Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

Intervention Type DRUG

30 days postoperative prophylactic treatment.

Interventions

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

Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

30 days postoperative prophylactic treatment.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Low Molecular Weight Heparin

Eligibility Criteria

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

Inclusion Criteria

1. Cancer located in oesophagus and/or cardia.
2. Candidate for intended curative surgery.
3. Age \> 18 years.

Exclusion Criteria

1. Known inherited bleeding disorder.
2. Unable to provide informed consent.
3. Arterial or venous thromboembolic events within the last three months.
4. On-going anticoagulant treatment (Vitamin K antagonists or direct oral anticoagulants).
5. Pregnant or has given birth within the last three months.
6. Known allergy to the trial drug Dalteparin (Fragmin®).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No