Clinical trial · Interventional
PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer
NCT00004891CI-TRIAL-00020280completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| computed tomography | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| radionuclide imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- primary resectable rectal cancer
- interventionNames
- 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
Primary outcomes (1)
- measure
- Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan
- timeFrame
- 2 years
- description
- 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
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTNahas 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 17882490
- RESULTGuillem 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 10813118
- DERIVEDGuillem 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 23187748