Carcinoma Clinical Trial
Official title:
Open, Multicenter Observational Study of Oxaliplatin Utilized in Combination Therapy for Adjuvant Treatment of Colon Carcinoma of Stage III After Complete Removal of the Primary Tumor and for Treatment of Metastasizing Colorectal Carcinoma.
| NCT number | NCT01942200 |
| Other study ID # | ONKOOXA01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2013 |
| Est. completion date | July 25, 2018 |
| Verified date | August 2018 |
| Source | Onkovis GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The main purpose of this observational study with Oxaliplatin onkovis is to determine the
number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose
under the special circumstances of ambulant chemotherapy.
Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This
includes provision of appropriate packaging sizes to decrease the excess quantity to be
discarded, and thus also follows this objective.
Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this
end, data regarding co-medication and adverse events are also collected.
| Status | Completed |
| Enrollment | 383 |
| Est. completion date | July 25, 2018 |
| Est. primary completion date | July 25, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician Exclusion Criteria: - According to the Oxaliplatin SmPC |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Practice | Elstra | |
| Germany | Practice | Leipzig | |
| Germany | Practice | Naunhof |
| Lead Sponsor | Collaborator |
|---|---|
| Onkovis GmbH | AKP Freiburg GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Quantity of Oxaliplatin onkovis needed per treatment cycle | Determine the quantity of Oxaliplatin onkovis needed per treatment cycle | up to 24 weeks | |
| Secondary | Adverse events during and after treatment | The number and type of adverse events during and after the intra-venous application of Oxaliplatin will be assessed and documented. | up to 24 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05283226 -
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
|
Phase 2 | |
| Active, not recruiting |
NCT04362072 -
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
|
Phase 4 | |
| Completed |
NCT04033991 -
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
|
||
| Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
| Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
| Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT01061645 -
Study of MOC31-PE in Antigen Positive Carcinomas
|
Phase 1 | |
| Terminated |
NCT00557596 -
A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00532155 -
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT00216372 -
Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
|
Phase 3 | |
| Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
| Recruiting |
NCT05752357 -
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
|
||
| Not yet recruiting |
NCT05023928 -
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
|
Phase 1 | |
| Completed |
NCT00446446 -
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
|
Phase 2 | |
| Recruiting |
NCT04566952 -
Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06112041 -
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
|
Phase 2 | |
| Completed |
NCT03562897 -
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
|
Phase 2 | |
| Recruiting |
NCT06013111 -
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04600206 -
Existential Distress in Patients With Advanced Cancer and Their Caregivers
|