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Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial (QUINTETT)

This study is currently recruiting participants.
Verified August 2017 by Richard Malthaner, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907543
First Posted: May 22, 2009
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Malthaner, Lawson Health Research Institute
  Purpose
The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.

Condition Intervention Phase
Esophageal Neoplasms Other: Preoperative treatment of chemotherapy and radiation Other: Postoperative treatment of chemotherapy and radiation Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase III Trial Comparing Preoperative Chemoradiation Therapy (Cisplatin, 5-FU and Radiotherapy Followed by Surgery) to Surgery Followed by Postoperative Chemoradiation (Cisplatin, Epirubicin, 5-FU, Radiotherapy) for Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Richard Malthaner, Lawson Health Research Institute:

Primary Outcome Measures:
  • Quality of life as assessed by FACT-E [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Safety and morbidity [ Time Frame: 1 year ]

Estimated Enrollment: 96
Study Start Date: April 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Neoadjuvant Treatment
Preoperative chemotherapy/radiotherapy treatment
Other: Preoperative treatment of chemotherapy and radiation
Cisplatin + 5FU with concurrent radiation followed by surgery
Experimental: Adjuvant Treatment
Postoperative chemotherapy/radiotherapy treatment
Other: Postoperative treatment of chemotherapy and radiation
Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation

Detailed Description:
Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20 cm from the incisors) or gastroesophageal junction are included.
  • No distant metastases (M0).
  • Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.
  • Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
  • Resectable mediastinal nodes are eligible.
  • No prior chemotherapy for this malignancy.
  • No prior radiotherapy that would overlap the field(s) treated in this study.
  • Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
  • Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion Criteria:

  • Cancers of the cervical esophagus (< 20 cm are excluded).
  • Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
  • Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
  • Patients with biopsy proven metastatic celiac nodes are ineligible.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907543


Contacts
Contact: Deb Lewis, BSc 519-685-8500 ext 75685 deb.lewis@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Richard Malthaner, MD    519-667-6835    richard.malthaner@lhsc.on.ca   
Contact: Deb Lewis, BSc    519-685-8500 ext 75685    deb.lewis@lhsc.on.ca   
Principal Investigator: Richard Malthaner, MD         
Sponsors and Collaborators
Richard Malthaner
Investigators
Principal Investigator: Richard Malthaner, MD London Health Sciences Centre
  More Information

Responsible Party: Richard Malthaner, Sponsor-Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00907543     History of Changes
Other Study ID Numbers: R-09-025
First Submitted: May 21, 2009
First Posted: May 22, 2009
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by Richard Malthaner, Lawson Health Research Institute:
esophageal carcinoma
chemotherapy
radiation
surgery
randomized clinical trial
Clinical Trial
Radiotherapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Epirubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action