Neoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab - TARZAN

Conditions

Rectal cancer

Brief summary

The primary endpoint is clinical complete and near-complete response rate (c(n)CR) assessed at week 12 post-radiotherapy

Detailed description

Safety: incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0), vital signs and clinical laboratory test results., Pre-operative treatment-related complications leading to delays in systemic treatment and/or surgery (excluding non-treatment-related and logistical reasons). Delays in surgery are defined as treatment-related delays beyond 4-6 weeks after the clinical decision has been made to operate, Relapse-free survival (RFS), defined as the time from study enrolment to disease recurrence or disease-related death during follow-up, Local recurrence rate (LRR) at 1 year follow-up, Proportion of patients who undergo organ preserving treatment defined as the patients who at evaluation at T12w are found to have a (near-) complete response and thus planned for watchful waiting or local excision., Pathological complete and near-complete response (pCR), defined as Mandard TRG 1-2, if available, Radiological tumor regression using MRI (ESGAR consensus guidelines)

Related papers

No related papers found yet.

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is clinical complete and near-complete response rate (c(n)CR) assessed at week 12 post-radiotherapy	—

Secondary

Measure	Time frame
Safety: incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0), vital signs and clinical laboratory test results., Pre-operative treatment-related complications leading to delays in systemic treatment and/or surgery (excluding non-treatment-related and logistical reasons). Delays in surgery are defined as treatment-related delays beyond 4-6 weeks after the clinical decision has been made to operate, Relapse-free survival (RFS), defined as the time from study enrolment to disease recurrence or disease-related death during follow-up, Local recurrence rate (LRR) at 1 year follow-up, Proportion of patients who undergo organ preserving treatment defined as the patients who at evaluation at T12w are found to have a (near-) complete response and thus planned for watchful waiting or local excision., Pathological complete and near-complete response (pCR), defined as Mandard TRG 1-2, if available, Radiological tumor regression using MRI (ESGAR consensus guidelines)	—

Measure

Time frame

Safety: incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0), vital signs and clinical laboratory test results., Pre-operative treatment-related complications leading to delays in systemic treatment and/or surgery (excluding non-treatment-related and logistical reasons). Delays in surgery are defined as treatment-related delays beyond 4-6 weeks after the clinical decision has been made to operate, Relapse-free survival (RFS), defined as the time from study enrolment to disease recurrence or disease-related death during follow-up, Local recurrence rate (LRR) at 1 year follow-up, Proportion of patients who undergo organ preserving treatment defined as the patients who at evaluation at T12w are found to have a (near-) complete response and thus planned for watchful waiting or local excision., Pathological complete and near-complete response (pCR), defined as Mandard TRG 1-2, if available, Radiological tumor regression using MRI (ESGAR consensus guidelines)

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Countries

Netherlands

Outcome results

None listed