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

NCT01523015 | Unknown Phase 2 DMC

• 2 other identifiers: EGC-0254/87/2011UML-EGC-2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adenocarcinoma; esophago-gastric cancer; chemotherapy; chemoradiotherapy; surgery

Outcome Measures

Primary Outcomes (1)

• Pathological response to treatment

  Pathological response to treatment assessed as a tumor regresion grade in histopahological assessment of the surgical specimen

  6-12 weeks after chemoradiotherapy

Secondary Outcomes (7)

• Clinical response to treatment

  5 weeks after chemoradiotherapy

• The curative resection (R0) rate

  6-12 weeks after chemoradiotherapy

• chemoradiotherapy related toxicity

  6-12 weeks after chemoradiotherapy

• postoperative complications rate

  30 days after surgical resection

• Overall and cancer free survival

  5 years from onset of the chemoradiotherapy

Study Arms (2)

Combined therapy

EXPERIMENTAL

The combined modality therapy will be consisted of preoperative chemoradiotherapy (Docetaxel, Oxaliplatin, 5-Fluorouracil, 45Gy) for type I i II cancer or preoperative chemotherapy (Docetaxel, Oxaliplatin, 5-Fluorouracil) for type III cancer and followed by surgery.

Other: preoperative chemo- and chemoradiotherapy

Surgery

ACTIVE COMPARATOR

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.

Procedure: Surgical resection

Interventions

preoperative chemo- and chemoradiotherapy OTHER

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

Also known as: docetaxel,, oxaliplatin,, 5-fluorouracil,, irradiation

Combined therapy

Surgical resection PROCEDURE

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.

Also known as: esophagectomy,, gastrectomy

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of both gender, aged more than 18, with histopathologically confirmed adenocarcinoma of the esophagogastric junction
• medically fit to undergo a major surgery with planned thoracotomy and in general condition allowing to tolerate chemo- or chemoradiotherapy (Karnofsky Performance Status ≥70, ECOG 0-1).
• Carcinoma of the esophagogastric junction defined as adenocarcinoma involving esophagogastric junction when its epicenter is localized within 5cm proximally or 5cm distally to the anatomical esophagogastric junction with subclassification to 3 topographic types (type I between 5cm and 1cm above; type II between 1cm above and 2cm below; type III between 2cm and 5cm below anatomic junction of the esophagus and the stomach).
• Potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0.
• The intended number of randomized patients has been set as 100: 50 patients randomized to each therapeutic arm with assumption, that 80% of randomized patients will complete the treatment protocol.

You may not qualify if:

• disseminated cancer
• poor general condition (KI \<70)
• adenocarcinoma of the stomach
• adenocarcinoma of the esophagus

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin

Lublin, Lublin Voivodeship, 20-081, Poland

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Chemoradiotherapy; Docetaxel; Oxaliplatin; Fluorouracil; Radiation; Esophagectomy; Gastrectomy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tomasz Skoczylas, MD, PhD

  Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Grzegorz Wallner, Professor

  Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Andrzej Dąbrowski, Professor

  Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Witold Zgodziński, MD, PhD

  Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Marek Majewski, MD, PhD

  Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Maria Mazurkiewicz, Professor

  Department of Oncology, Medical University of Lublin, Lublin Oncology Center

  PRINCIPAL INVESTIGATOR

• Anna Brzozowska, MD, PhD

  Department of Oncology, Medical University of Lublin, Lublin Oncology Center

  PRINCIPAL INVESTIGATOR

• Ludmiła Grzybowska-Szatkowska, MD, PhD

  Department of Oncology, Medical University of Lublin, Lublin Oncology Center

  PRINCIPAL INVESTIGATOR

• Witold Krupski, Professor

  Second Department of Radiology, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Ewa Kurys-Denis, MD, PhD

  Second Department of Radiology, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Justyna Szumiło, Professor

  Department of Clinical Pathomorphology, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

• Agnieszka Fronczek, MD

  Department of Clinical Pathomorphology, Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Skoczylas, MD, PhD

CONTACT

+48 81 5328810; tomskocz@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2020
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

PL (1)