Sarcoma, Soft TissuePhase 2NCT00204568
Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
A Phase 2 study testing Adriamycin and Trofosfamide in people with Sarcoma, Soft Tissue, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Adriamycin and Trofosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Oct 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·
- Grading II/III (Guillou et al. J Clin Oncol 1997)
- At least 1 measurable tumor parameter according to RECIST criteria
- Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)
- No previous radiation therapy of the only measurable lesion
- No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months
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- Patients aged 60 years and beyond
- Written patient informed consent
- ECOG Status 0-2
- Granulocytes >= 2 x 109/l and thrombocytes >= 100 x 10/l
- Serum creatinine, bilirubin < 1.5 times the upper limit of normal value, albumin > 25 g/l
- No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease
- Normal left-ventricular function by echocardiography or MUGA scan
- No symptomatic CNS metastases
- Willingness to receive regular follow-up examinations
Who cannot join
- Histological grading of malignancy: G I
- Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma
- Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
Kiel, 24105
About this study
Official title: Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma
The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).
Read the detailed description
Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Adriamycin, Trofosfamide
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdriamycinDrug
60 mg/m2, d1, W d22
TrofosfamideDrug
300 mg absolute d1-7, followed by 150 mg absolute continuously
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Adriamycin mono Receives: Drug: Adriamycin |
| 2 | Experimental | Trofosfamide Receives: Drug: Trofosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival after 6 months
Progression-free survival after 6 months
Measured: after 6 months
Secondary outcomes (1)
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30
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 startAug 2004
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group, French Sarcoma Group
- Responsible party
- Principal investigator, J. T. Hartmann, University Hospital Schleswig-Holstein
- Investigators
- Joerg T. Hartmann, MD, Principal investigator, University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204568
- Sponsor's protocol ID
- jth_001
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00204568
- Acronym / sponsor ID
- jth_001
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group, French Sarcoma Group
- Study start
- Aug 2004
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- 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.
The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).
Detailed description
Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AdriamycinAdriamycin mono |
| 2 | Experimental | Drug: TrofosfamideTrofosfamide |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·
- Grading II/III (Guillou et al. J Clin Oncol 1997)
- At least 1 measurable tumor parameter according to RECIST criteria
- Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)
- No previous radiation therapy of the only measurable lesion
Key exclusion criteria (3 listed)
- Histological grading of malignancy: G I
- Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma
- Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN
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 |
|---|---|---|
| Adriamycin60 mg/m2, d1, W d22 | Drug | 1 |
| Trofosfamide300 mg absolute d1-7, followed by 150 mg absolute continuously | Drug | 2 |
Primary outcome
Progression-free survival after 6 months
Time frame: after 6 months
Progression-free survival after 6 months
1 secondary outcome
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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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
University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
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 and Trofosfamide in people with Sarcoma, Soft Tissue, run by University Hospital Schleswig-Holstein 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 15 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jan 2013. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Progression-free survival after 6 months (time frame: after 6 months). It is what the study was designed to measure, not a finding.
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 8 Jan 2013.