Sarcoma, Soft TissuePhase 2NCT00204646
Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)
A Phase 2 study testing Adriamycin, Ifosfamide and Etoposide in people with Sarcoma, Soft Tissue, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Adriamycin, Ifosfamide and Etoposide
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Feb 1999to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Adriamycin, Ifosfamide, Etoposide, Carboplatin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdriamycinDrug
IfosfamideDrug
EtoposideDrug
CarboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 1999
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Joerg T. Hartmann, MD, Principal investigator, South West German Cancer Center, Medical Center II, University of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204646
- Sponsor's protocol ID
- jth_005
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00204646
- Acronym / sponsor ID
- jth_005
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Feb 1999
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adriamycin | Drug | – |
| Ifosfamide | Drug | – |
| Etoposide | Drug | – |
| Carboplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg T. Hartmann, MD principal investigator
South West German Cancer Center, Medical Center II, University of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adriamycin, Ifosfamide and Etoposide in people with Sarcoma, Soft Tissue, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.