Colorectal CancerNCT00004891
PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
A study testing chemotherapy, computed tomography and conventional surgery in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- chemotherapy, computed tomography and conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Mar 2007
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Primary resectable rectal cancer as determined by currently accepted diagnostic work-up, including CT scan and endorectal ultrasound (EUS)
- Must meet criteria for preoperative radiotherapy and chemotherapy:
- Bulky tumors and/or EUS evidence of T3-4 and/or N1 disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- No uncontrolled diabetes mellitus (i.e., greater than 175 mg/dL)
- No intolerance of being inside PET scanner for duration of study
- No vulnerable patients (e.g., mentally retarded or prisoners)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer
RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment.
PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.
Read the detailed description
OBJECTIVES:
- Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision.
- Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray.
OUTLINE: This is a diagnostic study conducted concurrently with multimodality management.
Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging. Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal.
Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients undergo surgical resection 1-2 weeks later.
PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 3 years.
- Conditions
- Colorectal Cancer
- Being tested
- chemotherapy, computed tomography, conventional surgery, neoadjuvant therapy, positron emission tomography
- Keywords
- stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
computed tomographyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
positron emission tomographyProcedure or surgery
radionuclide imagingProcedure or surgery
fludeoxyglucose F 18Radiation
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| primary resectable rectal cancer | Experimental | Not described Receives: Drug: chemotherapy; Procedure: computed tomography; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan
at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision
Measured: 2 years
Secondary outcomes (1)
Determine the accuracy of FDG-PET
in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1999
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jose G. Guillem, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004891
- Sponsor's protocol ID
- MSKCC-99048
- Other IDs
- CDR0000067567, NCI-G00-1695
- Status last verified
- Dec 2015
- First submitted
- 7 Mar 2000
- Last updated
- 22 Dec 2015
- Results posted
- No
Publications
Nahas CS, Akhurst T, Yeung H, Leibold T, Riedel E, Markowitz AJ, Minsky BD, Paty PB, Weiser MR, Temple LK, Wong WD, Larson SM, Guillem JG. Positron emission tomography detection of distant metastatic or synchronous disease in patients with locally advanced rectal cancer receiving preoperative chemoradiation. Ann Surg Oncol. 2008 Mar;15(3):704-11. doi: 10.1245/s10434-007-9626-y. Epub 2007 Sep 20.
PubMed 17882490Guillem JG, Puig-La Calle J Jr, Akhurst T, Tickoo S, Ruo L, Minsky BD, Gollub MJ, Klimstra DS, Mazumdar M, Paty PB, Macapinlac H, Yeung H, Saltz L, Finn RD, Erdi Y, Humm J, Cohen AM, Larson S. Prospective assessment of primary rectal cancer response to preoperative radiation and chemotherapy using 18-fluorodeoxyglucose positron emission tomography. Dis Colon Rectum. 2000 Jan;43(1):18-24. doi: 10.1007/BF02237238.
PubMed 10813118Guillem JG, Ruby JA, Leibold T, Akhurst TJ, Yeung HW, Gollub MJ, Ginsberg MS, Shia J, Suriawinata AA, Riedel ER, Mazumdar M, Saltz LB, Minsky BD, Nash GM, Paty PB, Temple LK, Weiser MR, Larson SM. Neither FDG-PET Nor CT can distinguish between a pathological complete response and an incomplete response after neoadjuvant chemoradiation in locally advanced rectal cancer: a prospective study. Ann Surg. 2013 Aug;258(2):289-95. doi: 10.1097/SLA.0b013e318277b625.
PubMed 23187748
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer
- ClinicalTrials.gov ID
- NCT00004891
- Acronym / sponsor ID
- MSKCC-99048
- Conditions
- Colorectal Cancer
- Keywords
- stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1999
- Primary completion
- Mar 2007 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment.
PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.
Detailed description
OBJECTIVES:
- Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision.
- Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray.
OUTLINE: This is a diagnostic study conducted concurrently with multimodality management.
Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging. Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal.
Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients undergo surgical resection 1-2 weeks later.
PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary resectable rectal cancer | Experimental | Drug: chemotherapy, Procedure: computed tomography, Procedure: conventional surgery, Procedure: neoadjuvant therapy, Procedure: positron emission tomography, Procedure: radionuclide imaging, Radiation: fludeoxyglucose F 18, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| chemotherapy | Drug | primary resectable rectal cancer |
| computed tomography | Procedure or surgery | primary resectable rectal cancer |
| conventional surgery | Procedure or surgery | primary resectable rectal cancer |
| neoadjuvant therapy | Procedure or surgery | primary resectable rectal cancer |
| positron emission tomography | Procedure or surgery | primary resectable rectal cancer |
| radionuclide imaging | Procedure or surgery | primary resectable rectal cancer |
| fludeoxyglucose F 18 | Radiation | primary resectable rectal cancer |
| radiation therapy | Radiation | primary resectable rectal cancer |
Primary outcome
Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan
Time frame: 2 years
at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision
1 secondary outcome
Determine the accuracy of FDG-PET
Time frame: 2 years
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 22 Dec 2015.
- Results publication: PubMed 17882490Nahas CS, Akhurst T, Yeung H, Leibold T, Riedel E, Markowitz AJ, Minsky BD, Paty PB, Weiser MR, Temple LK, Wong WD, Larson SM, Guillem JG. Positron emission tomography detection of distant metastatic or synchronous disease in patients with locally advanced rectal cancer receiving preoperative chemoradiation. Ann Surg Oncol. 2008 Mar;15(3):704-11. doi: 10.1245/s10434-007-9626-y. Epub 2007 Sep 20.
- Results publication: PubMed 10813118Guillem JG, Puig-La Calle J Jr, Akhurst T, Tickoo S, Ruo L, Minsky BD, Gollub MJ, Klimstra DS, Mazumdar M, Paty PB, Macapinlac H, Yeung H, Saltz L, Finn RD, Erdi Y, Humm J, Cohen AM, Larson S. Prospective assessment of primary rectal cancer response to preoperative radiation and chemotherapy using 18-fluorodeoxyglucose positron emission tomography. Dis Colon Rectum. 2000 Jan;43(1):18-24. doi: 10.1007/BF02237238.
- Derived from this study: PubMed 23187748Guillem JG, Ruby JA, Leibold T, Akhurst TJ, Yeung HW, Gollub MJ, Ginsberg MS, Shia J, Suriawinata AA, Riedel ER, Mazumdar M, Saltz LB, Minsky BD, Nash GM, Paty PB, Temple LK, Weiser MR, Larson SM. Neither FDG-PET Nor CT can distinguish between a pathological complete response and an incomplete response after neoadjuvant chemoradiation in locally advanced rectal cancer: a prospective study. Ann Surg. 2013 Aug;258(2):289-95. doi: 10.1097/SLA.0b013e318277b625.
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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.
Jose G. Guillem, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy, computed tomography and conventional surgery in people with Colorectal Cancer, run by Memorial Sloan Kettering 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?
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 22 Dec 2015. 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.
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?
Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan (time frame: 2 years). 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 NCT00004891, which also lists 3 linked publications.
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 22 Dec 2015.