Esophageal CancerPhase 2NCT00230451
Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
A Phase 2 study testing Radiation, Paclitaxel and Cisplatin in people with Esophageal Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Radiation, Paclitaxel and Cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Jul 2008
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
- No prior treatment allowed. No prior thoracic radiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48197
About this study
Official title: A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma
Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Radiation, Paclitaxel, Cisplatin, 5-Fluorouracil
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationProcedure or surgery
PaclitaxelDrug
CisplatinDrug
5-FluorouracilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
Secondary outcomes (2)
To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
To assess the qualitative and quantitative toxicities of this regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startNov 1997
- Primary completionDec 1999
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Susan Urba, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230451
- Sponsor's protocol ID
- UMCC 9740
- Status last verified
- Jan 2010
- First submitted
- 28 Sep 2005
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT00230451
- Acronym / sponsor ID
- UMCC 9740
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Nov 1997
- Primary completion
- Dec 1999 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 30 Sep 2005 (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.
Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
- No prior treatment allowed. No prior thoracic radiation.
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 |
|---|---|---|
| Radiation | Procedure or surgery | – |
| Paclitaxel | Drug | – |
| Cisplatin | Drug | – |
| 5-Fluorouracil | Drug | – |
Primary outcome
To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
2 secondary outcomes
To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
To assess the qualitative and quantitative toxicities of this regimen.
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 15 Jan 2010.
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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.
Susan Urba, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation, Paclitaxel and Cisplatin in people with Esophageal Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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 0 inclusion and 2 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 15 Jan 2010. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2010.