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 June 2011 by Lawson Health Research Institute
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00907543
First received: May 21, 2009
Last updated: June 29, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: April 2009
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Lawson Health Research Institute
Investigators
Principal Investigator: Richard Malthaner, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Richard Malthaner, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00907543     History of Changes
Other Study ID Numbers: R-09-025
Study First Received: May 21, 2009
Last Updated: June 29, 2011
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014