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

Summary

The high cancer related mortality has remained a significant issue of health care in Poland, Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction and esophagus has been observed in the developed countries. The most eminent drawback of majority commonly cited randomized trials is heterogenicity of cancer patient population. The epidemiological, pathological, and clinical data clearly suggest that adenocarcinoma of the esophago-gastric junction is the entirety different both from adenocarcinoma of the esophagus and adenocarcinoma of the stomach. The experience in a combined modality therapy for adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on esophageal or gastric cancer, where the investigated population involved in part patients with carcinoma of the esophago-gastric junction. The proposed study has been designed to achieve the following objectives:

* The assessment of safety and efficacy of a combined modality therapy in homogenous patient population with adenocarcinoma of the esophago-gastric junction excluding individuals with adenocarcinoma of the esophagus or the stomach;
* The assessment of safety of a combined modality therapy in a form of chemo- and chemoradiotherapy related toxicity and impact of chemo- and chemoradiotherapy on postoperative morbidity or mortality rates;
* The assessment of efficacy of a combined modality therapy in a form of rate of response of the tumor to chemo- and chemoradiotherapy and a curative resection rate.
* The assessment of efficacy of a combined modality therapy in a form of cancer free survival and overall survival.

Conditions

• Adenocarcinoma of the Gastroesophageal Junction

Interventions

OTHER

preoperative chemo- and chemoradiotherapy

2 cycles of triple regimen chemotherapy consisting of docetaxel (75mg/m2 iv infusion), oxaliplatin (130mg/m2 iv infusion) and 5-fluorouracil (750mg/m2 iv infusion followed by fractionated irradiation (total dose 45Gy in 25 fractions of 1,8Gy) combined with chemotherapy consisting of 3 cycles of 1-day chemotherapy with docetaxel (50mg/m2 iv infusion) and oxaliplatin (85mg/m2 iv infusion

PROCEDURE

Surgical resection

The extent of surgery will be associated with the topographic type of carcinoma of the esophagogastric junction: type I - subtotal esophagectomy with superior gastric resection, splenectomy and two-field mediastinal lymph node dissection; type II and III - total gastrectomy with distal esophagectomy, splenectomy and D2 with mediastinal inferior lymph node dissection.

Sponsors & Collaborators

• Medical University of Lublin

  lead OTHER

Principal Investigators

• Tomasz Skoczylas, MD, PhD · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

• Grzegorz Wallner, Professor · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

• Andrzej Dąbrowski, Professor · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

• Witold Zgodziński, MD, PhD · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

• Marek Majewski, MD, PhD · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

• Maria Mazurkiewicz, Professor · Department of Oncology, Medical University of Lublin, Lublin Oncology Center

• Anna Brzozowska, MD, PhD · Department of Oncology, Medical University of Lublin, Lublin Oncology Center

• Ludmiła Grzybowska-Szatkowska, MD, PhD · Department of Oncology, Medical University of Lublin, Lublin Oncology Center

• Witold Krupski, Professor · Second Department of Radiology, Medical University of Lublin

• Ewa Kurys-Denis, MD, PhD · Second Department of Radiology, Medical University of Lublin

• Justyna Szumiło, Professor · Department of Clinical Pathomorphology, Medical University of Lublin

• Agnieszka Fronczek, MD · Department of Clinical Pathomorphology, Medical University of Lublin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2015-12-31

Completion

2020-12-31

Countries

• Poland

Study Locations