Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)
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ClinicalTrials.gov Identifier: NCT00204646 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: April 20, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Soft Tissue | Drug: Adriamycin Drug: Ifosfamide Drug: Etoposide Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas |
Study Start Date : | February 1999 |
Actual Study Completion Date : | December 2006 |


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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed STS with locally advanced non-resectable disease
- Metastatic disease is allowed in case of solitary resectable metastases
- Grading according to Coindre > II°
- Measurable tumor lesions
- Age > 18 through 65 years
- Karnofsky status > 70 %
- Written informed consent
Exclusion Criteria:
- Prior chemotherapy
- Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease
- Insufficient liver-, renal or bone marrow function
- Evidence of pregnancy
- Treatment within another clinical trial
- Uncontrolled viral Infections (HIV,HBV, HCV)
- other malignancies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204646
Germany | |
Medical Center II, University of Tuebingen | |
Tuebingen, Germany, 72076 |
Principal Investigator: | Joerg T. Hartmann, MD | South West German Cancer Center, Medical Center II, University of Tuebingen |
ClinicalTrials.gov Identifier: | NCT00204646 History of Changes |
Other Study ID Numbers: |
jth_005 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | April 20, 2007 |
Last Verified: | April 2007 |
Additional relevant MeSH terms:
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Isophosphamide mustard Liposomal doxorubicin Carboplatin Etoposide Ifosfamide Doxorubicin |
Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents Antibiotics, Antineoplastic |