Esophageal CancerNCT01243619
FLT PET/CT for Staging, Target Definition and Assessment of Response to Therapy in Patients With Esophageal Cancer
A study testing 3'-deoxy-3'-(18) F-fluorothymidine in people with Esophageal Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this pilot study is to develop a more advanced software program that will collect, compare and analyze tumor images for evaluation. Another purpose of this study is to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT) can improve the evaluation of tumors during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- 3'-deoxy-3'-(18) F-fluorothymidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction. Biopsy or cytology of the primary tumor, or of involved regional lymph nodes, is acceptable.
- Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic ultrasound. T1 tumors are eligible if they are T1, N1, M0. Regional thoracic lymph node involvement is permitted.
- Disease must be clinically limited to the esophagus or gastroesophageal junction. If the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction. Adenocarcinomas of the distal esophagus would therefore include tumors of the gastroesophageal junction which involve equally both the distal esophagus and proximal stomach, or Siewert type II. Tumor much be surgically resectable and have a minimum length of 2cm.
- Patients must be judged by their oncologist to be a candidate for combined modality therapy with chemotherapy consisting of oxaliplatin with protracted infusion 5-FU and concurrent radiation.
- FDG PET/CT performed off-site must be available for review by the Overall PI in DICOM format and has been performed within one month of study entry
- 18 years of age or older
- ECOG Performance Status 0-1
- Laboratory values as outlined in the protocol
Who cannot join
- No prior chemotherapy or radiotherapy is permitted. Patients must be at least 4 weeks since major surgery, or must have recovered from the effects of minor surgery.
- No prior malignancies (other than basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted unless diagnosed and/or treated 3 years or longer before registration and without evidence of recurrence.
- Patients with the following tumor characteristics are not eligible: TIS (in situ carcinoma); tumors determined to be T1N0 following endoscopic ultrasound; supraclavicular (for distal tumors) or celiac (for proximal tumors) lymph node involvement, as determined by EUS, CT scan, or PET scan, unless this is proven to be a false positive by an appropriate biopsy; cervical esophageal tumors, or gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus; no patients with tracheoesophageal fistulas
- Patients with evidence of metastatic disease
- No poorly controlled diabetes despite attempts to improve glucose control by fasting duration and adjustment of medications
- Pregnant and breast feeding women are excluded
- HIV-positive individuals on combination antiretroviral therapy are ineligible
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 3'-Deoxy-3'(18) F-Fluorothymidine Positron Emission Tomography/Computed Tomography (PET/CT) for Initial Staging, Radiotherapy Target Definition, and Assessment of Response to Therapy in Patients With Esophageal Cancer: A Pilot Study
The purpose of this pilot study is to develop a more advanced software program that will collect, compare and analyze tumor images for evaluation. Another purpose of this study is to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT) can improve the evaluation of tumors during a PET/CT scan. This new type of image tracking is meant to improve the visualization of tumor active and size.
Read the detailed description
- The following are standard medical procedures that are part of regular cancer care that the participant would probably have done even if they did not join the study: Chemotherapy; physical examination; pregnancy test (if applicable); diagnostic FDG-PET/CT scan before and after treatment to evaluate disease.
- The following diagnostic procedures are being done specifically because of this study: Three FLT-PET/CT scans before, during and after treatment and one FDG PET/CT scan during treatment.
- Participants will be in this research study for approximately 12-14 weeks.
- Conditions
- Esophageal Cancer
- Being tested
- 3'-deoxy-3'-(18) F-fluorothymidine
- Keywords
- PET, CT, 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.
3'-deoxy-3'-(18) F-fluorothymidineDrug
Also called FLT
Radio-tracer for tumor imaging
| Study group | Role | What they receive |
|---|---|---|
| FLT PET | Experimental | This is a single arm trial, in which all patients receive three FDG-PET scans and three FLT-PET scans, before, during and after pre-operative chemoradiation for esophageal cancer. Receives: Drug: 3'-deoxy-3'-(18) F-fluorothymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis
Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.
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 posted18 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Harvey Mamon, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Harvey J. Mamon, MD, PhD, Principal investigator, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243619
- Sponsor's protocol ID
- 10-169
- Status last verified
- Apr 2017
- First submitted
- 30 Sep 2010
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3'-Deoxy-3'(18) F-Fluorothymidine Positron Emission Tomography/Computed Tomography (PET/CT) for Initial Staging, Radiotherapy Target Definition, and Assessment of Response to Therapy in Patients With Esophageal Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT01243619
- Acronym / sponsor ID
- 10-169
- Conditions
- Esophageal Cancer
- Keywords
- PET, CT, radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Aug 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Posted 5 Mar 2015
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 pilot study is to develop a more advanced software program that will collect, compare and analyze tumor images for evaluation. Another purpose of this study is to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT) can improve the evaluation of tumors during a PET/CT scan. This new type of image tracking is meant to improve the visualization of tumor active and size.
Detailed description
- The following are standard medical procedures that are part of regular cancer care that the participant would probably have done even if they did not join the study: Chemotherapy; physical examination; pregnancy test (if applicable); diagnostic FDG-PET/CT scan before and after treatment to evaluate disease.
- The following diagnostic procedures are being done specifically because of this study: Three FLT-PET/CT scans before, during and after treatment and one FDG PET/CT scan during treatment.
- Participants will be in this research study for approximately 12-14 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT PET | Experimental | Drug: 3'-deoxy-3'-(18) F-fluorothymidineThis is a single arm trial, in which all patients receive three FDG-PET scans and three FLT-PET scans, before, during and after pre-operative chemoradiation for esophageal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction. Biopsy or cytology of the primary tumor, or of involved regional lymph nodes, is acceptable.
- Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic ultrasound. T1 tumors are eligible if they are T1, N1, M0. Regional thoracic lymph node involvement is permitted.
- Disease must be clinically limited to the esophagus or gastroesophageal junction. If the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction. Adenocarcinomas of the distal esophagus would therefore include tumors of the gastroesophageal junction which involve equally both the distal esophagus and proximal stomach, or Siewert type II. Tumor much be surgically resectable and have a minimum length of 2cm.
- Patients must be judged by their oncologist to be a candidate for combined modality therapy with chemotherapy consisting of oxaliplatin with protracted infusion 5-FU and concurrent radiation.
- FDG PET/CT performed off-site must be available for review by the Overall PI in DICOM format and has been performed within one month of study entry
Key exclusion criteria (7 listed)
- No prior chemotherapy or radiotherapy is permitted. Patients must be at least 4 weeks since major surgery, or must have recovered from the effects of minor surgery.
- No prior malignancies (other than basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted unless diagnosed and/or treated 3 years or longer before registration and without evidence of recurrence.
- Patients with the following tumor characteristics are not eligible: TIS (in situ carcinoma); tumors determined to be T1N0 following endoscopic ultrasound; supraclavicular (for distal tumors) or celiac (for proximal tumors) lymph node involvement, as determined by EUS, CT scan, or PET scan, unless this is proven to be a false positive by an appropriate biopsy; cervical esophageal tumors, or gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus; no patients with tracheoesophageal fistulas
- Patients with evidence of metastatic disease
- No poorly controlled diabetes despite attempts to improve glucose control by fasting duration and adjustment of medications
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 |
|---|---|---|
| 3'-deoxy-3'-(18) F-fluorothymidineAlso: FLTRadio-tracer for tumor imaging | Drug | FLT PET |
Primary outcome
Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis
Time frame: 1 year
Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Harvey J. Mamon, MD, PhD principal investigator
Dana-Farber/Brigham and Women's Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3'-deoxy-3'-(18) F-fluorothymidine in people with Esophageal Cancer, run by Dana-Farber Cancer Institute at 3 sites 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 8 inclusion and 7 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis (time frame: 1 year). 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 17 May 2017.