Esophagus CancerPhase 2NCT00193141
Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
A Phase 2 study testing Paclitaxel, Carboplatin and 5-Fluorouracil in people with Esophagus Cancer, run by SCRI Development Innovations, LLC.
Trial summary
In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Paclitaxel, Carboplatin and 5-Fluorouracil
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 1999to Jul 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in this study, you must meet the following criteria:
- Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
- Received no previous treatment for esophageal cancer.
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
Show all 9Show fewer
- Be at least 3 weeks from any major surgical procedures.
- Have an indwelling central venous access catheter.
- Patients must be able to understand the nature consent of the study and give written informed consent.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Age < 18 years
- History of a prior malignancy within the past 5 years
- History of significant heart disease
- Inoperable on the basis of co-existent medical problems
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.
Read the detailed description
Upon determination of eligibility, all patients will receive neo-adjuvant therapy with:
Paclitaxel + Carboplatin + 5-Fluorouracil + Radiation
After neo-adjuvant therapy and restaging are completed, patients will be randomized to receive one of two treatments:
- Surgical resection (Arm A)
- Paclitaxel + Carboplatin + Radiation (Arm B)
- Conditions
- Esophagus Cancer
- Being tested
- Paclitaxel, Carboplatin, 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.
PaclitaxelDrug
CarboplatinDrug
5-FluorouracilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer
Secondary outcomes (3)
To compare the toxicity of these two treatment approaches in localized esophageal cancer
To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment
To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 1999
- Primary completionOct 2004
- Study completionJul 2007
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 Esophagus CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193141
- Sponsor's protocol ID
- SCRI GI 23
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2011
- Results posted
- No
Publications
Hainsworth JD, Meluch AA, Gray JR, Spigel DR, Meng C, Bearden JD, Hermann R, Greco FA. Concurrent chemoradiation followed by esophageal resection vs chemoradiation alone for localized esophageal cancer. Community Oncology 4:431-439, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00193141
- Acronym / sponsor ID
- SCRI GI 23
- Conditions
- Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 1999
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 19 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.
In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.
Detailed description
Upon determination of eligibility, all patients will receive neo-adjuvant therapy with:
Paclitaxel + Carboplatin + 5-Fluorouracil + Radiation
After neo-adjuvant therapy and restaging are completed, patients will be randomized to receive one of two treatments:
- Surgical resection (Arm A)
- Paclitaxel + Carboplatin + Radiation (Arm B)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
- Received no previous treatment for esophageal cancer.
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (6 listed)
- Age < 18 years
- History of a prior malignancy within the past 5 years
- History of significant heart disease
- Inoperable on the basis of co-existent medical problems
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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 |
|---|---|---|
| Paclitaxel | Drug | – |
| Carboplatin | Drug | – |
| 5-Fluorouracil | Drug | – |
Primary outcome
To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer
3 secondary outcomes
To compare the toxicity of these two treatment approaches in localized esophageal cancer
To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment
To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment.
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 3 May 2011.
- Results publicationHainsworth JD, Meluch AA, Gray JR, Spigel DR, Meng C, Bearden JD, Hermann R, Greco FA. Concurrent chemoradiation followed by esophageal resection vs chemoradiation alone for localized esophageal cancer. Community Oncology 4:431-439, 2007.
- Community Oncology articleLink provided by the sponsor.
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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.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Carboplatin and 5-Fluorouracil in people with Esophagus Cancer, run by SCRI Development Innovations, LLC.
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 6 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 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer. 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 NCT00193141, 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 3 May 2011.