Clinical trial · Interventional
FDG-PET-CT and Biomarkers in Esophageal Cancer
FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation
- 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)
The goal of this clinical research study is to learn if the results of a positron emission tomography/computed tomography (PET/CT) scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation) can predict how a patient with cancer of the esophagus will respond to chemoradiation. Researchers also want to learn if biomarkers (substances in the body associated with cancer) found in tumor tissue can predict response to chemoradiation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Testings | Other | — | UNRESOLVED |
| PET/CT (FDG PET/CT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT Scan + Biomarkers Testing
- description
- PET/CT scan with fluorodeoxyglucose (FDG) solution by vein, scan done 10-14 days after beginning chemotherapy and radiation (chemoradiation). Tissue obtained at MDACC during previous biopsy and at time of post chemoradiation surgery will be used for biomarker analysis.
- interventionNames
- Procedure: PET/CT (FDG PET/CT)
- Other: Biomarker Testings
Primary outcomes (1)
- measure
- Pathologic Response
- timeFrame
- PET-CT at 12 + 2 days after the start of chemoradiation
- description
- From baseline PET-CT to "early" PET-CT \[12 + 2 days after the start of chemoradiation\] Frequency and percentage of pathologic complete response (pathCR) and extreme chemoradiation resistance (exCRTR) patients tabulated. Exploratory graphics, such as box plots, used to illustrate distribution of PET/CT maximum SUV by pathCR (or exCRTR) status. A logistic regression model fit for pathCR (and separately, for exCRTR), with baseline and the change of maximum SUV between baseline and early chemoradiation included as covariates.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of the esophagus at M. D. Anderson Cancer Center (MDACC). 2. Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at MDACC and are considered appropriate candidates for and are willing to undergo chemoradiation therapy followed by surgery at MDACC. Radiation may be delivered as proton or photon. These patients have clinical stage II or III cancers and they are considered medically fit to undergo surgery. 3. Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at MDACC, with tissue available for biomarker analysis. 4. Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution. 5. Patient must be willing to undergo a research "early" FDG-PET/CT (12 +/- 2 days from the start of chemoradiation). 6. Patient must provide written informed consent. 7. Patient must be \>/= 18 years of age. Exclusion Criteria: 1. Patient is unable or unwilling to comply with the requirements of the protocol. 2. Patient had baseline FDG-PET/CT scan maximum SUV of \< 4.0. 3. Patient is not a candidate for chemoradiation followed by surgery. 4. Patients who received induction chemotherapy prior to chemoradiation therapy are excluded. 5. Patients with T1N0 or T4anyN are excluded.
References
Publications (1)
- DERIVEDElimova E, Wang X, Etchebehere E, Shiozaki H, Shimodaira Y, Wadhwa R, Planjery V, Charalampakis N, Blum MA, Hofstetter W, Lee JH, Weston BR, Bhutani MS, Rogers JE, Maru D, Skinner HD, Macapinlac HA, Ajani JA. 18-fluorodeoxy-glucose positron emission computed tomography as predictive of response after chemoradiation in oesophageal cancer patients. Eur J Cancer. 2015 Nov;51(17):2545-52. doi: 10.1016/j.ejca.2015.07.044. Epub 2015 Aug 28. PMID 26321501