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Soft Tissue SarcomaPhase 2NeoWTSNCT01382030

Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma

A Phase 2 study testing EIA chemotherapy in people with Soft Tissue Sarcoma, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
EIA chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
Jun 2005to Jan 2011
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

  • Soft tissue sarcoma histology
  • Tumor size >= 5 cm
  • Deep/extracompartimental localization
  • Grade 2/3 (FNCLCC)
  • Patients with inadequate previous therapy
  • Age 18-65 years
Show all 10Show fewer
  • normal bone marrow function
  • normal liver function
  • normal renal function
  • Karnofsky index >=80%

Who cannot join

  • Chordoma
  • Chondrosarcoma
  • Kaposi´ sarcoma
  • Neuroblastoma
  • Mesothelioma
  • Osteosarcoma/Ewings´sarcoma

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Heidelberg University Clinics

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma

Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Read the detailed description

The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Being tested
EIA chemotherapy
Keywords
Soft tissue sarcoma, High-risk, Neoadjuvant, Adjuvant, Chemotherapy, Radiotherapy
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EIA chemotherapyDrug

    ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1

Study groups in NCT01382030
Study groupRoleWhat they receive
Treatment ArmExperimentalAll patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.
Receives: Drug: EIA chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.

    Measured: 2 years after study completion

Secondary outcomes (8)

  1. Overall Survival

    Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.

    Measured: 2 years after study completion

  2. Grade of histological necrosis

    Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.

    Measured: After definite surgery, approx. 12-15 weeks after study inclusion

  3. Hematological toxicity

    Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.

    Measured: Once weekly for an average of 8 months

  4. Renal Toxicity

    Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.

    Measured: Once weekly for an average of 8 months

  5. Liver Toxicity

    Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.

    Measured: Once weekly for an average of 8 months

  6. Correlation of Tumor Necrosis and Decline in PET SUV

    Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.

    Measured: After tumor resection, approx. 12-15 weeks after study inclusion

  7. Cardiac Toxicity

    Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.

    Measured: Every 6 weeks for an average of 8 months

  8. Radiologic Tumor Response

    Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.

    Measured: Every 6 weeks for an average of 8 months, then every 3 months for 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startJun 2005
  3. Primary completionSep 2010
  4. Study completionJan 2011

Resources

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)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382030
Sponsor's protocol ID
2004-002501-72
Other IDs
2004-002501-72, 2004
Acronym
NeoWTS
Status last verified
Jun 2011
First submitted
17 Jun 2011
Last updated
27 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Roeder F, Lehner B, Schmitt T, Kasper B, Egerer G, Sedlaczek O, Grullich C, Mechtersheimer G, Wuchter P, Hensley FW, Huber PE, Debus J, Bischof M. Excellent local control with IOERT and postoperative EBRT in high grade extremity sarcoma: results from a subgroup analysis of a prospective trial. BMC Cancer. 2014 May 20;14:350. doi: 10.1186/1471-2407-14-350.

    PubMed 24885755

  • Schmitt T, Lehner B, Kasper B, Bischof M, Roeder F, Dietrich S, Dimitrakopoulou-Strauss A, Strauss LG, Mechtersheimer G, Wuchter P, Ho AD, Egerer G. A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma. BMC Cancer. 2011 Dec 7;11:510. doi: 10.1186/1471-2407-11-510.

    PubMed 22152120

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EIA chemotherapy in people with Soft Tissue Sarcoma, run by Heidelberg University 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 10 inclusion and 6 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 27 Jun 2011. 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.

What does the primary outcome measure?

Disease-free survival (time frame: 2 years after study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382030, which also lists 2 linked publications.

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 27 Jun 2011.

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