An observational study in Pancreas Metastases and Colorectal Cancer, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational
Among 427 studies in Colorectal Neoplasms with a site in Italy — 103 open to participants now, 143 under way, 18 of them phase 3. Colorectal Neoplasms · Italy.
Among the 427 studies in Colorectal Neoplasms with a site in Italy, this one is the 91st largest by planned enrollment of the 94 observational ones that give a count, is one of 25 that started in 2023, is one of 94 observational ones, and was the 329th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →103 of the 427 studies in Colorectal Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
Azienda USL Reggio Emilia - IRCCS · Sites in Italy
Ages 18+
Blue Earth Diagnostics · Sites in Italy, Netherlands
Ages 18–79
EMD Serono Research & Development Institute, Inc. · Sites in Italy, United States, Argentina and 16 more countries
Ages 18+
Gruppo Oncologico Italia Meridionale · Sites in Italy
Ages 18+
Incyte Corporation · Sites in Italy, United States, Argentina and 19 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
427 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 81 · Phase 2 155 · Phase 3 81 · Phase 4 3
First in 1988; this study’s year is marked. 25 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Median enrollment 215 across the 329 interventional studies, 265 across the 94 observational. Of the 226 that completed or were terminated, 97 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
213 of 427 have an industry lead sponsor. The 10 most frequent:
Ospedale Generale Di Zona Moriggia-Pelascini is the lead sponsor of 36 studies on the registry; none are open to participants now.
Ospedale Generale Di Zona Moriggia-Pelascini has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
41 of the studies in Colorectal Neoplasms with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07792109Fondazione Policlinico Universitario Agostino Gemelli IRCCSImplementation Of A Telesurgery Program At A Referral Center For Robotic Surgery | 2026-11-30 |
| NCT02919644Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSVaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer. | 2026-12 |
| NCT05789069HiFiBiO TherapeuticsA Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors | 2026-12 |
| NCT05205330Rottapharm BiotechVorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers | 2026-12 |
| NCT07116668SafeHeal IncSafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study | 2026-12 |
Among the 427 studies in Colorectal Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, we intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
Primary objective;
Secondary objective:
Metastases to the Pancreas are quite rare and account for less than 5% of pancreatic malignancies diagnosed in living patients.
In autopsy cases of malignant tumours, the incidence of pancreatic secondary tumours reaches 15%.
The metastases are predominantly of epithelial origin, most commonly from lung, stomach, small bowel, colon-rectum, kidney , breast , liver , ovary ,melanoma and urinary bladder.
It is largely described that resection of isolated metastasis to the lung or liver from primary tumour leads to improved survival; yet there is no consensus about the benefit of pancreas resection for metastases and the gold standard treatment is still not well defined.
The lack of data for pancreas metastases resections depends on low incidence and high perioperative risks. However, the improvement in morbidity and mortality rates after pancreaticoduodenectomy made the indication for this operation acceptable.
One of the larger series concluded that an aggressive surgical approach might be warranted if the patient can be rendered free of disease.
The majority of case series referred to renal cell carcinoma and resection for CCR are episodic. However there are several reports of solitary resected pancreatic metastases from colorectal cancer There is currently very limited experience with the surgical resection of isolated pancreatic colorectal metastases, and the role of surgery in the management of these patients is still debated.
To date, no prospective randomized or case-controlled studies have been performed to evaluate the role of surgical resection. Additionally, many of the existing retrospective studies are limited because of the small number of patients who were treated during prolonged periods of time.
Aim of the study The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, the investigators intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
The investigators launched the study aiming at demonstrating that pancreatic resection for colorectal metastases may be a safe and feasible procedure in selected patients and may provide long-term survival. The investigators sought to address the role of surgical resection and survival benefit from surgery. The investigators suppose to achieve a good prognosis with a median survival close to that observed after resection of hepatic metastases.
The guidelines for the treatment of colorectal cancer recommend resection of hematogenous metastases if they are deemed resectable.
Study design This study is an international multicenter retrospective cohort study to assess the outcomes of patients that underwent pancreas resection for solitary colorectal metastasis.
Aim of surgical interventions is to remove metastases in association to radical lymphadenectomy thus to achieve R0 result.
Patient data will be retrospectively analyzed and demographic characteristics, comorbidity status, clinical and radiological findings, treatment strategies , 30-day morbidity and mortality, oncological outcomes at 6 and 12 months will be evaluated.
patients underwent pancreas surgery for colorectal metastasis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
total-pancreatectomy distal-pancreatectomy other metastases resection
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient underwent a pancreas resection (whipple, distal pancreasectomy ...) with inclusion criteria. Criteria Inclusion Criteria: * Isolated pancreatic metastases from Colorectal cancer * Previous surgery for colorectal cancer * Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas * Other procedures: total-pancreatectomy distal-pancreatectomy other metastases resection * R0 resection * no signs of peritoneal metastasis or tumor manifestations outside of the pancreas. * CT Scan before surgery Exclusion Criteria: * metastases from different malignancies * other malignancies * surgically unmanageable lesions * Multiple synchronous colorectal metastasis
Procedure: Pancreas surgery
Criteria Inclusion Criteria: * Isolated pancreatic metastases from Colorectal cancer * Previous surgery for colorectal cancer * Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas pancreaticoduodenectomy total-pancreatectomy distal-pancreatectomy other metastases resection
30-day mortality
assessed by the number of patients with pancreas resection deceased within 30-days from the surgical intervention
Time frame: 30 days
30-day morbidity
assessed by the number of patients with pancreatic resection who experienced any type of postoperative complication within 30-days from the surgical intervention
Time frame: 30 days
Overall survival
6 moths survival 3. Survival : 6 moths survival 4. Disease free survival at 6 months
Time frame: 6 months
Disease free survival
disease free survival at 6 months
Time frame: 6 months
Overall survival (12)
Overall survival at 12 months
Time frame: 12 months
Disease free survival (12)
disease free survival at 12 months
Time frame: 12 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Mar 2023, 2 months after the start.
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ospedale Generale Di Zona Moriggia-Pelascini