Neoplasms, Rectal
Conditions
Brief summary
cCR12 as assessed by ICR, defined as maintenance of cCR for 12 months. The 12-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR.
Detailed description
cCR24 as assessed by ICR, defined as maintenance of cCR for 24 months. The 24-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR., cCR36 as assessed by ICR, defined as maintenance of cCR for 36 months. The 36-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR, EFS3 as assessed by investigator assessment, defined as remaining alive and free of 1) disease progression precluding surgery, 2) local recurrence, and 3) distant recurrence, as assessed by investigator at 3 years from the first dose of study intervention.
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cCR12 as assessed by ICR, defined as maintenance of cCR for 12 months. The 12-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR. | — |
Secondary
| Measure | Time frame |
|---|---|
| cCR24 as assessed by ICR, defined as maintenance of cCR for 24 months. The 24-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR., cCR36 as assessed by ICR, defined as maintenance of cCR for 36 months. The 36-month period starts from the first disease assessment after last dose of study intervention that demonstrates cCR by ICR, EFS3 as assessed by investigator assessment, defined as remaining alive and free of 1) disease progression precluding surgery, 2) local recurrence, and 3) distant recurrence, as assessed by investigator at 3 years from the first dose of study intervention. | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed