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

Primary Purpose

Esophageal Neoplasms

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Preoperative treatment of chemotherapy and radiation

Postoperative treatment of chemotherapy and radiation

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Neoadjuvant Treatment

Adjuvant Treatment

Arm Description

Preoperative chemotherapy/radiotherapy treatment

Postoperative chemotherapy/radiotherapy treatment

Outcomes

Primary Outcome Measures

Quality of life as assessed by FACT-E

Secondary Outcome Measures

Safety and morbidity

Full Information

NCT ID

NCT00907543

First Posted

May 21, 2009

Last Updated

March 4, 2019

Sponsor

Richard Malthaner

1. Study Identification

Unique Protocol Identification Number

NCT00907543

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 2009 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Richard Malthaner

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms

Keywords

esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant Treatment

Arm Type

Other

Arm Description

Preoperative chemotherapy/radiotherapy treatment

Arm Title

Adjuvant Treatment

Arm Type

Experimental

Arm Description

Postoperative chemotherapy/radiotherapy treatment

Intervention Type

Other

Intervention Name(s)

Preoperative treatment of chemotherapy and radiation

Intervention Description

Cisplatin + 5FU with concurrent radiation followed by surgery

Intervention Type

Other

Intervention Name(s)

Postoperative treatment of chemotherapy and radiation

Intervention Description

Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation

Primary Outcome Measure Information:

Title

Quality of life as assessed by FACT-E

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Safety and morbidity

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Malthaner, MD

Organizational Affiliation

London Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

35611396

Citation

Malthaner RA, Yu E, Sanatani M, Lewis D, Warner A, Dar AR, Yaremko BP, Bierer J, Palma DA, Fortin D, Inculet RI, Frechette E, Raphael J, Gaede S, Kuruvilla S, Younus J, Vincent MD, Rodrigues GB. The quality of life in neoadjuvant versus adjuvant therapy of esophageal cancer treatment trial (QUINTETT): Randomized parallel clinical superiority trial. Thorac Cancer. 2022 Jul;13(13):1898-1915. doi: 10.1111/1759-7714.14433. Epub 2022 May 24.

Results Reference

derived

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

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