Esophageal CancerPRIDENCT03474341
Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal Cancer
An observational study of Esophageal Cancer and Esophageal Adenocarcinoma, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
Rationale: For locally advanced esophageal cancer the standard treatment consists of 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Surgery is currently performed independent of the response to nCRT and is associated with substantial morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
- What is being tested?
- MRI, PET-CT and Endoscopy
- How many people
- 200 participants
- Where
- 4 sitesNetherlands
- Study dates
- 9 Apr 2018to Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resectable esophageal or gastroesophageal junction adeno- or squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy according to the CROSS-regimen
Who may be able to join
- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction (i.e. tumors involving both cardia and esophagus on endoscopy)
- Potentially resectable locally advanced esophageal tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and 18F-FDG PET-CT
- Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen1: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4 Gray in 23 fractions, 5 days per week) followed by esophagectomy
- Age > 18 years
Who cannot join
- Patients who meet exclusion criteria for MRI
- Patients who meet exclusion criteria for intravenous gadolinium-based contrast:
- Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2
- Nephrogenic Systemic Fibrosis (strict contra-indication for gadolinium-based contrast)
- Known allergy for gadolinium-based contrast
- Patients with a blood plasma glucose concentration >10 mmol/L or poorly controlled diabetes mellitus
- Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
- Pregnant or breast-feeding patients
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam University Medical Centers, Academic Medical Center
Amsterdam
Hanneke WM van Laarhoven, MD, PhD
- Not yet recruiting
Antoni van Leeuwenhoek - Netherlands Cancer Institute (NKI-AVL)
Amsterdam
Marcel Verheij, MD, PhD
- Recruiting
University Medical Center Groningen (UMCG)
Groningen
J. (Hans) A. Langendijk, MD, PhD
- Recruiting
University Medical Center Utrecht (UMCU)
Utrecht, 3584 CX
Gert Meijer, PhD
About this study
Rationale: For locally advanced esophageal cancer the standard treatment consists of 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Surgery is currently performed independent of the response to nCRT and is associated with substantial morbidity. Prior knowledge of the eventual response to nCRT would greatly impact on the optimal care for many esophageal cancer patients for two imperative reasons:
Firstly, it is argued that patients who achieved a pathologic complete response (pCR, 29%) may not have benefitted from surgery. Consequently, proper identification of pathological complete responders prior to surgery could yield an organ-preserving regimen avoiding unnecessary toxicity.
Read more
Secondly, non-responders are exposed to the side effects of nCRT without showing any tumor regression. Early identification of the non-responders during nCRT would be beneficial for this group as ineffective therapy could be stopped, and for who altered treatment strategies could be explored.
Objective: To develop a multimodal model that predicts the probability of pathologic complete response to nCRT in esophageal cancer, by integrating diffusion weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in conjunction with combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (18F-FDG PET-CT) scans acquired prior to, during and after administration of nCRT.
Study design: Multi-center observational study
Study population: Patients (>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT prior to surgery.
Intervention: In addition to the standard diagnostic work-up for esophageal cancer that includes a 18F-FDG PET-CT scan at diagnosis and after nCRT, one 18F-FDG PET-CT scans will be performed during nCRT, as well as three MRI scans (before, during and after nCRT) within fixed time intervals. Furthermore, after response imaging after nCRT has been performed, but prior to surgery, patients will undergo (on an opt-out basis) an endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site, other suspected lesions and suspected lymph nodes. Furthermore, blood samples will be collected at three time points.
Main study parameters/endpoints: An accurate multimodal prediction model for the patients' individual probability of pathologic complete response after nCRT, based on the quantitative parameters derived from a longitudinal series of DW-MRI, DCE-MRI and 18F-FDG PET-CT datasets.
- Conditions
- Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
- Being tested
- MRI, PET-CT, Endoscopy, Blood samples
- Keywords
- Neoadjuvant chemoradiotherapy (nCRT), Pathologic complete response (pCR), Magnetic Resonance Imaging (MRI), PET-CT, Circulating tumor DNA (ctDNA), endoscopy
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Magnetic Resonance Imaging, DW-MRI, DCE-MRI, T2W
- Anatomical (T2W) and functional MRI (DWI and DCE) at a 1.5T Siemens or Philips scanner
- DWI series: sagittal (sIVIM) and high-resolution transversal (HR tDWI)
- DCE serie: dynamic20
- In total, three MRI scan series (before, during, after nCRT)
- Measurements: i.a. change in apparent diffusion coefficient (ADC) or area-under-the-gadolinium-concentration time curve (AUC) within tumor delineation over time, radiological (qualitative) assessment of residual disease
PET-CTDiagnostic test
Also called 18-F FDG PET-CT, PET
- According to European Association of Nuclear Medicine (EANM) Research Ltd guidelines (EARL)
- In total one additional PET-CT (during nCRT) for study purposes. A PET-CT scan at diagnosis and after nCRT are included in the standard diagnostic work-up for esophageal cancer.
- Measurements: i.a. change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value) or Ktrans within tumor delineation over time
EndoscopyDiagnostic test
Also called Endoscopic assessment, EUS
Additional endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site and other suspected lesions in the esophagus after completion of nCRT and prior to surgery
Blood samplesDiagnostic test
Also called ctDNA
- Blood samples at three different time points (before, during and after nCRT) will be collected
- Blood will be collected in cell-free DNA collection tubes
- Purpose: isolation of ctDNA and subsequent mutation analysis by means of Next Generation Sequencing
- Measurements: the presence of, and changes in, ctDNA during nCRT
| Study group | Role | What they receive |
|---|---|---|
| Resectable esophageal squamous cell- or adenocarcinoma | Patients (>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT according to the CROSS regimen prior to surgery.
CROSS regimen: weekly carboplatin (doses titrated to achieve an area under the curve of 2 mg per milliliter per minute) and paclitaxel (50 mg per square meter of body-surface area) for 5 weeks and concurrent radiotherapy (41.4 Gy in 23 fractions, delivered 5 days per week on workdays with intensity modulated radiotherapy, including photon and proton therapy) Receives: Diagnostic Test: MRI; Diagnostic Test: PET-CT; Diagnostic Test: Endoscopy; Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathologic response
Histopathologic response of the primary tumor to nCRT according to the tumor regression grade (TRG) scale as determined by expert pathologist.
TRG 1: no residual viable tumor cells, pathologic complete response TRG 2: rare residual cancer cells TRG 3: predominant fibrosis with increased number of residual cancer cells TRG 4: residual cancer outgrowing fibrosis or no regressive change
Measured: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)
Secondary outcomes (3)
Pathological T- and N-stage
Pathological T- and N-stage as determined by expert pathologist (based on the American Joint Committee on Cancer [AJCC] Tumor Node Metastasis [TNM] staging system)
Measured: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)
Disease-free survival.
Disease-free survival based on local follow-up policies (time to locoregional or distal recurrence of esophageal cancer).
Measured: Up to 5-year follow-up
Overall survival.
Overall survival based on local follow-up policies.
Measured: Up to 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start9 Apr 2018
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, The Netherlands Cancer Institute, Koningin Wilhelmina Fonds, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Gert Meijer, UMC Utrecht
- Investigators
- Gert J Meijer, PhD, Principal investigator, UMC UtrechtMarcel Verheij, MD, PhD, Principal investigator, Antoni van Leeuwenhoek - Netherlands Cancer InstituteJ. (Hans) A. Langendijk, MD, PhD, Principal investigator, University Medical Center GroningenHanneke WM van Laarhoven, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474341
- Sponsor's protocol ID
- NL62881.041.17
- Other IDs
- Project ID 10291, 17-941
- Acronym
- PRIDE
- Status last verified
- Nov 2020
- First submitted
- 30 Jan 2018
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borggreve AS, Mook S, Verheij M, Mul VEM, Bergman JJ, Bartels-Rutten A, Ter Beek LC, Beets-Tan RGH, Bennink RJ, van Berge Henegouwen MI, Brosens LAA, Defize IL, van Dieren JM, Dijkstra H, van Hillegersberg R, Hulshof MC, van Laarhoven HWM, Lam MGEH, van Lier ALHMW, Muijs CT, Nagengast WB, Nederveen AJ, Noordzij W, Plukker JTM, van Rossum PSN, Ruurda JP, van Sandick JW, Weusten BLAM, Voncken FEM, Yakar D, Meijer GJ; PRIDE study group. Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study. BMC Cancer. 2018 Oct 20;18(1):1006. doi: 10.1186/s12885-018-4892-6.
PubMed 30342494
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03474341
- Acronym / sponsor ID
- PRIDE / NL62881.041.17
- Conditions
- Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
- Keywords
- Neoadjuvant chemoradiotherapy (nCRT), Pathologic complete response (pCR), Magnetic Resonance Imaging (MRI), PET-CT, Circulating tumor DNA (ctDNA), endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, The Netherlands Cancer Institute, Koningin Wilhelmina Fonds, Amsterdam UMC, location VUmc
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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: For locally advanced esophageal cancer the standard treatment consists of 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Surgery is currently performed independent of the response to nCRT and is associated with substantial morbidity. Prior knowledge of the eventual response to nCRT would greatly impact on the optimal care for many esophageal cancer patients for two imperative reasons:
Firstly, it is argued that patients who achieved a pathologic complete response (pCR, 29%) may not have benefitted from surgery. Consequently, proper identification of pathological complete responders prior to surgery could yield an organ-preserving regimen avoiding unnecessary toxicity.
Secondly, non-responders are exposed to the side effects of nCRT without showing any tumor regression. Early identification of the non-responders during nCRT would be beneficial for this group as ineffective therapy could be stopped, and for who altered treatment strategies could be explored.
Objective: To develop a multimodal model that predicts the probability of pathologic complete response to nCRT in esophageal cancer, by integrating diffusion weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in conjunction with combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (18F-FDG PET-CT) scans acquired prior to, during and after administration of nCRT.
Study design: Multi-center observational study
Study population: Patients (>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT prior to surgery.
Intervention: In addition to the standard diagnostic work-up for esophageal cancer that includes a 18F-FDG PET-CT scan at diagnosis and after nCRT, one 18F-FDG PET-CT scans will be performed during nCRT, as well as three MRI scans (before, during and after nCRT) within fixed time intervals. Furthermore, after response imaging after nCRT has been performed, but prior to surgery, patients will undergo (on an opt-out basis) an endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site, other suspected lesions and suspected lymph nodes. Furthermore, blood samples will be collected at three time points.
Main study parameters/endpoints: An accurate multimodal prediction model for the patients' individual probability of pathologic complete response after nCRT, based on the quantitative parameters derived from a longitudinal series of DW-MRI, DCE-MRI and 18F-FDG PET-CT datasets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resectable esophageal squamous cell- or adenocarcinoma | – | Diagnostic Test: MRI, Diagnostic Test: PET-CT, Diagnostic Test: Endoscopy, Diagnostic Test: Blood samplesPatients (>18 years) with potentially resectable locally advanced squamous cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT according to the CROSS regimen prior to surgery. CROSS regimen: weekly carboplatin (doses titrated to achieve an area under the curve of 2 mg per milliliter per minute) and paclitaxel (50 mg per square meter of body-surface area) for 5 weeks and concurrent radiotherapy (41.4 Gy in 23 fractions, delivered 5 days per week on workdays with intensity modulated radiotherapy, including photon and proton therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resectable esophageal or gastroesophageal junction adeno- or squamous cell carcinoma, scheduled to receive neoadjuvant chemoradiotherapy according to the CROSS-regimen
Key inclusion criteria (4 listed)
- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction (i.e. tumors involving both cardia and esophagus on endoscopy)
- Potentially resectable locally advanced esophageal tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and 18F-FDG PET-CT
- Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen1: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4 Gray in 23 fractions, 5 days per week) followed by esophagectomy
- Age > 18 years
Key exclusion criteria (8 listed)
- Patients who meet exclusion criteria for MRI
- Patients who meet exclusion criteria for intravenous gadolinium-based contrast:
- Patients with a blood plasma glucose concentration >10 mmol/L or poorly controlled diabetes mellitus
- Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy
- Pregnant or breast-feeding patients
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 |
|---|---|---|
| MRIAlso: Magnetic Resonance Imaging, DW-MRI, DCE-MRI, T2W* Anatomical (T2W) and functional MRI (DWI and DCE) at a 1.5T Siemens or Philips scanner * DWI series: sagittal (sIVIM) and high-resolution transversal (HR tDWI) * DCE serie: dynamic20 * In total, three MRI scan series (before, during, after nCRT) * Measurements: i.a. change in apparent diffusion coefficient (ADC) or area-under-the-gadolinium-concentration time curve (AUC) within tumor delineation over time, radiological (qualitative) assessment of residual disease | Diagnostic test | Resectable esophageal squamous cell- or adenocarcinoma |
| PET-CTAlso: 18-F FDG PET-CT, PET* According to European Association of Nuclear Medicine (EANM) Research Ltd guidelines (EARL) * In total one additional PET-CT (during nCRT) for study purposes. A PET-CT scan at diagnosis and after nCRT are included in the standard diagnostic work-up for esophageal cancer. * Measurements: i.a. change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value) or Ktrans within tumor delineation over time | Diagnostic test | Resectable esophageal squamous cell- or adenocarcinoma |
| EndoscopyAlso: Endoscopic assessment, EUSAdditional endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site and other suspected lesions in the esophagus after completion of nCRT and prior to surgery | Diagnostic test | Resectable esophageal squamous cell- or adenocarcinoma |
| Blood samplesAlso: ctDNA* Blood samples at three different time points (before, during and after nCRT) will be collected * Blood will be collected in cell-free DNA collection tubes * Purpose: isolation of ctDNA and subsequent mutation analysis by means of Next Generation Sequencing * Measurements: the presence of, and changes in, ctDNA during nCRT | Diagnostic test | Resectable esophageal squamous cell- or adenocarcinoma |
Primary outcome
Histopathologic response
Time frame: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)
Histopathologic response of the primary tumor to nCRT according to the tumor regression grade (TRG) scale as determined by expert pathologist. TRG 1: no residual viable tumor cells, pathologic complete response TRG 2: rare residual cancer cells TRG 3: predominant fibrosis with increased number of residual cancer cells TRG 4: residual cancer outgrowing fibrosis or no regressive change
3 secondary outcomes
Pathological T- and N-stage
Time frame: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)
Disease-free survival.
Time frame: Up to 5-year follow-up
Overall survival.
Time frame: Up to 5-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Derived from this study: PubMed 30342494Borggreve AS, Mook S, Verheij M, Mul VEM, Bergman JJ, Bartels-Rutten A, Ter Beek LC, Beets-Tan RGH, Bennink RJ, van Berge Henegouwen MI, Brosens LAA, Defize IL, van Dieren JM, Dijkstra H, van Hillegersberg R, Hulshof MC, van Laarhoven HWM, Lam MGEH, van Lier ALHMW, Muijs CT, Nagengast WB, Nederveen AJ, Noordzij W, Plukker JTM, van Rossum PSN, Ruurda JP, van Sandick JW, Weusten BLAM, Voncken FEM, Yakar D, Meijer GJ; PRIDE study group. Preoperative image-guided identification of response to neoadjuvant chemoradiotherapy in esophageal cancer (PRIDE): a multicenter observational study. BMC Cancer. 2018 Oct 20;18(1):1006. doi: 10.1186/s12885-018-4892-6.
- Individual participant dataSharing planned: Undecided
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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.
Gert J Meijer, PhD principal investigator
UMC Utrecht
Marcel Verheij, MD, PhD principal investigator
Antoni van Leeuwenhoek - Netherlands Cancer Institute
J. (Hans) A. Langendijk, MD, PhD principal investigator
University Medical Center Groningen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Esophageal Adenocarcinoma, run by UMC Utrecht at 4 sites in Netherlands.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gert J Meijer, PhD (0031 88-75 55555, pride@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathologic response (time frame: Based on resection specimen (surgery 8-10 weeks after finishing nCRT)). 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 NCT03474341, which also lists 1 linked publication.
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 16 Nov 2020.