Esophageal NeoplasmsQUINTETTNCT00907543
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial
A study testing Preoperative treatment of chemotherapy and radiation and Postoperative treatment of chemotherapy and radiation in people with Esophageal Neoplasms, run by Richard Malthaner at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Preoperative treatment of chemotherapy and radiation and Postoperative treatment of chemotherapy and radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Esophageal Neoplasms
- Being tested
- Preoperative treatment of chemotherapy and radiation, Postoperative treatment of chemotherapy and radiation
- Keywords
- esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative treatment of chemotherapy and radiationOther
Cisplatin + 5FU with concurrent radiation followed by surgery
Postoperative treatment of chemotherapy and radiationOther
Surgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment | Other | Preoperative chemotherapy/radiotherapy treatment Receives: Other: Preoperative treatment of chemotherapy and radiation |
| Adjuvant Treatment | Experimental | Postoperative chemotherapy/radiotherapy treatment Receives: Other: Postoperative treatment of chemotherapy and radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as assessed by FACT-E
Measured: 1 year
Secondary outcomes (1)
Safety and morbidity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startApr 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Malthaner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Malthaner, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Richard Malthaner, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907543
- Sponsor's protocol ID
- R-09-025
- Acronym
- QUINTETT
- Status last verified
- Mar 2019
- First submitted
- 21 May 2009
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35611396
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00907543
- Acronym / sponsor ID
- QUINTETT / R-09-025
- Conditions
- Esophageal Neoplasms
- Keywords
- esophageal carcinoma, chemotherapy, radiation, surgery, randomized clinical trial, Clinical Trial, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Richard MalthanerUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment | Other | Other: Preoperative treatment of chemotherapy and radiationPreoperative chemotherapy/radiotherapy treatment |
| Adjuvant Treatment | Experimental | Other: Postoperative treatment of chemotherapy and radiationPostoperative chemotherapy/radiotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative treatment of chemotherapy and radiationCisplatin + 5FU with concurrent radiation followed by surgery | Other | Neoadjuvant Treatment |
| Postoperative treatment of chemotherapy and radiationSurgery followed by cisplatin + 5FU + epirubicin as indicated by pathological stage with extended beam radiation | Other | Adjuvant Treatment |
Primary outcome
Quality of life as assessed by FACT-E
Time frame: 1 year
1 secondary outcome
Safety and morbidity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Derived from this study: PubMed 35611396Malthaner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Malthaner, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative treatment of chemotherapy and radiation and Postoperative treatment of chemotherapy and radiation in people with Esophageal Neoplasms, run by Richard Malthaner at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life as assessed by FACT-E (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00907543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.