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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Lawson Health Research Institute
Information provided by (Responsible Party):
Richard Malthaner, Lawson Health Research Institute Identifier:
First received: May 21, 2009
Last updated: October 3, 2016
Last verified: October 2016
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 Blind (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 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: April 2017
Estimated Primary Completion Date: April 2017 (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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00907543

Contact: Deb Lewis, BSc 519-685-8500 ext 75685

Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Richard Malthaner, MD    519-667-6835   
Contact: Deb Lewis, BSc    519-685-8500 ext 75685   
Principal Investigator: Richard Malthaner, MD         
Sponsors and Collaborators
Richard Malthaner
Principal Investigator: Richard Malthaner, MD London Health Sciences Centre
  More Information

Responsible Party: Richard Malthaner, Sponsor-Investigator, Lawson Health Research Institute Identifier: NCT00907543     History of Changes
Other Study ID Numbers: R-09-025
Study First Received: May 21, 2009
Last Updated: October 3, 2016

Keywords provided by Lawson Health Research Institute:
esophageal carcinoma
randomized clinical trial
Clinical Trial

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017