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

Esophageal Neoplasms Clinical Trial

— QUINTETT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907543
• Other study ID #: R-09-025
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Other:
• Preoperative treatment of chemotherapy and radiation
Cisplatin + 5FU with concurrent radiation followed by surgery
• Postoperative treatment of chemotherapy and radiation
Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Richard Malthaner

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as assessed by FACT-E		1 year
Secondary	Safety and morbidity		1 year