JPRN-UMIN000018217CompletedPhase 2
A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER - JACCRO CC-13 study
Japan Clinical Cancer Research Organization0 sites359 target enrollmentStarted: July 15, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 359
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Suspicious of Lynch syndrome (3) Brain metastases. (4) Infectious disease. (5) Interstitial lung disease or pulmonary fibrosis. (6) Comorbidity or history of serious heart failure. (7) History of thromboembolic events. (8) Cerebrovascular disease. (9) History of hemoptysis/hematemesis. (10) Uncontrolled hypertension.(systolic BP>180mmHg, or diastolic BP>100mmHg) (11) Sensory alteration or paresthesia interfering with function. (12) Large quantity of pleural, abdominal or cardiac effusion. (13) Severe comorbidity (renal failure, liver failure, hypertension, etc) (14) Prior radiotherapy for primary and metastases leision. (15) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (16) History of severe allergy. (17) HBsAg positive or active viral hepatitis. (18) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (19) Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 28 days. (20) Systemaic administration of antiplatelet drug or NSAIDs. (21) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (22) History of gastrointestinal perforation within 1 year. (23) Unhealed traumatic bone fracture. (24) Uncontrolled diarrhea. (25) History of organ recipient . (26) Prior cetuximab/bevacizumab/Irinotecan/Oxaliplatin treatment.(Adjuvant therapy by Oxaliplatin is excluded) (27) Administration of atazanavir sulfate. (28) Jaundice. (29) Ileus or bowel obstruction. (30) Any other cases who are regarded as inadequate for study enrollment by investigators.
Investigators
Similar Trials
Active, not recruiting
Phase 2
A randomized phase II study of FOLFOXIRI plus cetuximab versus FOLFOXIRI plus bevacizumab in metastatic colorectal cancer patients with RAS wild-type tumorscolorectal cancerJPRN-jRCTs061180022TSUJI Akihito360
Completed
Phase 2
A randomized phase II study for the evaluation of T cell depleted non-myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapyKahlers disease10035227Multiple MyelomaNL-OMON36688HOVO110
Completed
Phase 2
A randomized phase 2 trial which investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer.advanced hepatobiliary and pancreatic cancer patientsJPRN-UMIN000015105Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology40
Active, not recruiting
Not Applicable
/ASubjects affected by non-segmental vitiligoMedDRA version: 14.1Level: PTClassification code 10062080Term: Pigmentation disorderSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2011-000169-10-ITCLINUVEL PHARMACUETICALS LTD.60
Active, not recruiting
Phase 1
A randomized phase II study to investigate the addition of PD-L1 antibody MEDI4736 to a taxane-anthracycline containing chemotherapy in triple negative breast cancer.(GeparNuevo)MedDRA version: 20.1Level: LLTClassification code 10071115Term: Node-negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Patients with triple negative, early breast cancerMedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10071113Term: Node-positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006199Term: Breast cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-002714-72-DEGBG Forschungs GmbH174