Trial record 7 of 208 for:
Open Studies | "Esophageal Neoplasms"
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial (QUINTETT)
This study is currently recruiting participants.
Verified June 2011 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
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
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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
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 Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013