NCT00004891

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

7.5 years

First QC Date

March 7, 2000

Last Update Submit

December 21, 2015

Conditions

Colorectal Cancer

Keywords

stage II rectal cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • Determine the accuracy of FDG-PET

    2 years

Study Arms (1)

primary resectable rectal cancer

EXPERIMENTAL
Drug: chemotherapyProcedure: computed tomographyProcedure: conventional surgeryProcedure: neoadjuvant therapyProcedure: positron emission tomographyProcedure: radionuclide imagingRadiation: fludeoxyglucose F 18Radiation: radiation therapy

Interventions

chemotherapyDRUG
primary resectable rectal cancer
computed tomographyPROCEDURE
primary resectable rectal cancer
conventional surgeryPROCEDURE
primary resectable rectal cancer
neoadjuvant therapyPROCEDURE
primary resectable rectal cancer
positron emission tomographyPROCEDURE
primary resectable rectal cancer
radionuclide imagingPROCEDURE
primary resectable rectal cancer
fludeoxyglucose F 18RADIATION
primary resectable rectal cancer
radiation therapyRADIATION
primary resectable rectal cancer

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (3)

  • 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.

    PMID: 17882490RESULT

  • Guillem 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.

    PMID: 10813118RESULT

  • Guillem 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.

    PMID: 23187748DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Interventions

Drug TherapyNeoadjuvant TherapyMagnetic Resonance SpectroscopyFluorodeoxyglucose F18Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality TherapySpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Jose G. Guillem, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

March 1, 2007

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

US(1)