Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma
Schlüsselwörter
Abstrakt
Beschreibung
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.
Termine
| Zuletzt überprüft: | 05/31/2011 |
| Zuerst eingereicht: | 06/16/2011 |
| Geschätzte Einschreibung eingereicht: | 06/22/2011 |
| Zuerst veröffentlicht: | 06/26/2011 |
| Letztes eingereichtes Update: | 06/22/2011 |
| Letztes Update veröffentlicht: | 06/26/2011 |
| Tatsächliches Startdatum der Studie: | 05/31/2005 |
| Geschätztes primäres Abschlussdatum: | 08/31/2010 |
| Voraussichtliches Abschlussdatum der Studie: | 12/31/2010 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Treatment Arm
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Experimental: Treatment Arm All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized. | Drug: Treatment Arm 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 |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | Inclusion Criteria: - Soft tissue sarcoma histology - Tumor size >= 5 cm - Deep/extracompartimental localization - Grade 2/3 (FNCLCC) - Patients with inadequate previous therapy - Age 18-65 years - normal bone marrow function - normal liver function - normal renal function - Karnofsky index >=80% Exclusion Criteria: - Chordoma - Chondrosarcoma - Kaposi´ sarcoma - Neuroblastoma - Mesothelioma - Osteosarcoma/Ewings´sarcoma |
Ergebnis
Primäre Ergebnismaße
1. Disease-free survival [2 years after study completion]
Sekundäre Ergebnismaße
1. Overall Survival [2 years after study completion]
2. Grade of histological necrosis [After definite surgery, approx. 12-15 weeks after study inclusion]
3. Hematological toxicity [Once weekly for an average of 8 months]
4. Renal Toxicity [Once weekly for an average of 8 months]
5. Liver Toxicity [Once weekly for an average of 8 months]
6. Correlation of Tumor Necrosis and Decline in PET SUV [After tumor resection, approx. 12-15 weeks after study inclusion]
7. Cardiac Toxicity [Every 6 weeks for an average of 8 months]
8. Radiologic Tumor Response [Every 6 weeks for an average of 8 months, then every 3 months for 2 years]
