Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE... | NCT00204646

Studies
Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)

NCT00204646

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Apr 20, 2007Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Sarcoma, Soft Tissue

Interventions

Adriamycin
Ifosfamide
Etoposide
Carboplatin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1999

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2007

Last Update Posted Date

Apr 20, 2007Estimated

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joerg T. Hartmann, MD	South West German Cancer Center, Medical Center II, University of Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center II, University of Tuebingen		Tübingen		72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004317	Doxorubicin
D007069	Ifosfamide
D005047	Etoposide
D016190	Carboplatin

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Adriamycin	Drug
Ifosfamide	Drug
Etoposide	Drug
Carboplatin	Drug