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This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR/MSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.
The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1).
Secondary objectives are:
To describe the activity of neoadjuvant dostarlimab in terms of:
To describe the safety of neoadjuvant dostarlimab in terms of: Adverse events/SAE incidence and outcome, time and duration of toxicity according to CTCAE v5.0.
To descrive the efficacy of neoadjuvant dostarlimab in terms of: event free-survival (EFS), organ preservation at 3 years, time to ditance recurrence and overall survival (OS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage II-III rectal cancer (LARC) | patients with dMMR/MSI LARC treated with neoadjuvant dostarlimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab 500 mg iv every 3 weeks for 9 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1. | after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| duration of clinical complete response | defined as the time from the first documented date of clinical complete response to the date of documented local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first. | up to to 12 months |
| near-complete clinical response rate |
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Inclusion Criteria:
For the retrospective part of the study:
For the prospective part of the study:
- Inclusion in the AIFA dostarlimab monitoring registry for the indication in rectal cancer, to receive dostarlimab according to the Italian law 648/1996, GU n.252 as of 27/10/2023
Exclusion Criteria:
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Patients (any sex/gender) with dMMR/MSI-H locally advanced rectal cancer treated with dostarlimab are eligible for this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Carmela Piccirillo, MD | Contact | +39 08117770280 | m.piccirillo@istitutotumori.na.it | |
| Piera Gargiulo, MD | Contact | +39 081 1777 0279 | piera.gargiulo@istitutotumori.na.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Carmela Piccirillo, MD | National Cancer Institute, IRCCS Fondazione G. Pascale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica | Not yet recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
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absence of mass at digital rectal exam, small mucosal irregularity or superficial ulcer no more than 2 cm in diameter at endoscopic exam, and no metastatic nodes at MRI. |
| at 6 and 12 months up to 12 months |
| duration of near-complete clinical response | defined as the time from the first documented date of near-complete clinical response to the date of documented conversion to complete clinical response, local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first. | up to 12 months |
| rate of surgery (total mesorectal excision or local excision) | defined as the proportion of patients who undergo surgical resection of the primary tumor, including either total mesorectal excision (TME) or local excision | at 6 months (at the end of neoadjuvant dostarlimab) |
| pathological complete response rate | defined as a Tumor Regression Grade (TRG) 1 according to Mandard modified scoring system. | after surgery (at 6 months) |
| objective response rate assessed by central radiological review | defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1. | fter 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months |
| safety of neoadjuvant dostarlimab | Adverse events/Serious adverse events incidence and grading according to NCI-CTCAE v. 5.0 | at the end of each cycle of dostarlimab (every 21 days ) up to 6 months |
| Event-free survival | defined as the time between dostarlimab starting and disease recurrence (local or distant), or disease progression (radiological or clinical) or second primary colorectal malignancy, or death from any cause, whichever comes first. | up to 12 months |
| Time to distant recurrence | defined as the time between dostarlimab starting and distant disease recurrence or progression. Patients who do not have a distant recurrence and are alive at the end of the study will be censored at the date of the last assessment visit. | up to 12 months |
| Overall survival | defined as the time between dostarlimab starting and death from any cause. Patients alive at the end of the study will be censored at the date of the last follow-up contact. | up to 12 months |
| IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale | Recruiting | Naples | Italy |
|