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

Sponsor

Richard Malthaner (Other)

Overall Status

Completed

CT.gov ID

NCT00907543

Collaborator

(none)

Enrollment

Location

Arms

117

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms	Other: Preoperative treatment of chemotherapy and radiation Other: Postoperative treatment of chemotherapy and radiation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Actual Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Quality of life as assessed by FACT-E [1 year]

Secondary Outcome Measures

Safety and morbidity [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.