NCT00907543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

9.8 years

First QC Date

May 21, 2009

Last Update Submit

March 4, 2019

Conditions

Esophageal Neoplasms

Keywords

esophageal carcinomachemotherapyradiationsurgeryrandomized clinical trialClinical TrialRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Quality of life as assessed by FACT-E

    1 year

Secondary Outcomes (1)

  • Safety and morbidity

    1 year

Study Arms (2)

Neoadjuvant Treatment

OTHER

Preoperative chemotherapy/radiotherapy treatment

Other: Preoperative treatment of chemotherapy and radiation

Adjuvant Treatment

EXPERIMENTAL

Postoperative chemotherapy/radiotherapy treatment

Other: Postoperative treatment of chemotherapy and radiation

Interventions

Preoperative treatment of chemotherapy and radiationOTHER

Cisplatin + 5FU with concurrent radiation followed by surgery

Neoadjuvant Treatment
Postoperative treatment of chemotherapy and radiationOTHER

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

Adjuvant Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35611396DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Richard Malthaner, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

April 1, 2009

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

CA(1)