Klinische Studien

RAMIRIS

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
AIO-STO-04152015-005171-24

Ramucirumab plus Irinotecan / Leucovorin / 5-FU versus Ramucirumab plus Paclitaxel in patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, who failed one prior line of palliative chemotherapy

Status: Active

Purpose / Objectives

Primary Outcome

• To compare overall survival (OS) in patients with locally
advanced, inoperable or metastatic esophagogastric
adenocarcinoma receiving FOLFIRI with ramucirumab versus
paclitaxel with ramucirumab as second line therapy in patients
who failed prior taxane-containing therapy in the intent to treat
population (ITT) and where OS is defined as the time from
randomization to death from any cause
• To compare Objective Overall Response Rate (ORR) in the
groups as described above and where ORR is defined as the
proportion of patients with complete or partial remission
according to RECIST 1.1

Secondary Outcomes

To compare the treatment arms in terms of
• Disease Control Rate (DCR) as defined as proportion of
patients with complete or partial remission or stable disease
(CR, PR, SD) according to RECIST 1.1
• Progression free survival (PFS) defined as the time from
randomization to disease progression or death from any cause
• Quality of life (QoL) as measured by EORTC-QLQ-C30 during
treatment and follow-up (until d30 after EOT) and/or until
progression, or start of new anticancer therapy.

Diagnosis

Patients with locally advanced, inoperable or metastatic
adenocarcinoma of stomach or gastroesophageal junction are eligible
for this study.

Target population

Age

18-

Inclusion criteria

Histologically proven gastric adenocarcinoma including
adenocarcinoma of the esophagogastric junction
Metastatic or locally advanced disease, not amenable to potentially
curative resection
Phase II only: Documented objective radiological or clinical disease
progression during or within 6 months of the last dose of first-line
platinum and fluoropyrimidine doublet with or without anthracycline
or docetaxel. Neoadjuvant/adjuvant treatment is not counted
unless progression occurs <6 months after completion of the
treatment. In these cases neoadjuvant/adjuvant treatment is
counted as one line.
OR
Phase III only: Radiological or clinical disease progression during
or after the last dose of a first-line platinum, fluoropyrimidinecontaining therapy. Patients must also have received a taxane with
the first-line or during their adjuvant or neoadjuvant therapy or
both. Neoadjuvant/adjuvant platinum containing therapy is
permitted and is counted as first-line therapy if progression occurs
<12 months after completion of the treatment. If progression
occurred ≥ 12 months after completion of neoadjuvant/adjuvant
therapy, the therapy is not counted as a treatment line. At decision
of the investigator, different regimens can be considered as one
line of prior treatment, in case these were administrated as a
sequential or alternating therapy

Exclusion criteria

1. Other tumor type than adenocarcinoma (e.g. leiomyosarcoma,
lymphoma) or a second cancer except in patients with squamous
or basal cell carcinoma of the skin or carcinoma in situ of the cervix
that has been effectively treated. Patients curatively treated and
disease-free for at least 5 years will be discussed with the sponsor
before inclusion
2. Squamous gastric cancer3. Concurrent chronic systemic immune therapy, chemotherapy, or
hormone therapy not indicated in the study protocol
4. Phase II only: Previous therapy with paclitaxel or FOLFIRI;
Phase III only: Previous therapy with FOLFIRI
5. Current treatment with any anti-cancer therapy ≤ 2 weeks prior to
study treatment start unless rapidly progressing disease is
measured
6. Concurrent treatment with any other anti-cancer therapy
7. Previous exposure to a VEGF or VEGFR inhibitor or any
antiangiogenic agent, or prior enrolment in this study
8. Patient has undergone major surgery within 28 days prior to first
dose of protocol therapy, or minor surgery/subcutaneous venous
access device placement within 7 days prior to first dose of
protocol therapy. The patient has elective or planned major
surgery to be performed during the course of the clinical trial
9. Grade 3-4 GI bleeding within 3 months prior to enrollment
10. History of deep vein thrombosis (DVT), pulmonary embolism (PE),
or any other significant thromboembolism (venous port or catheter
thrombosis or superficial venous thrombosis are not considered
“significant”) during the 3 months prior to first dose of protocol
therapy
11. Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any
degree) and a history of hepatic encephalopathy or clinically
meaningful ascites resulting from cirrhosis. Clinically meaningful
ascites is defined as ascites from cirrhosis requiring diuretics or
paracentesis.

Study design

  • Phase III
  • Multicenter
  • Randomized

Documents (password protected)

Responsibilities in overall study

Study Sites

Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg

Address
Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg
Klinikum Nürnberg Nord
Prof.-Ernst-Nathan-Str. 1
90419 Nürnberg
Haus: Bau 12

Status

Active

 
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