Sarcoma, Soft Tissue
Conditions
Keywords
Sarcoma, soft tissue sarcoma, neoadjuvant chemotherapy, neoadjuvant radiotherapy, hypofractionated radiotherapy
Brief summary
Prospective phase II study. Patients will be submitted to neoadjuvant chemotherapy (cT) and hypo fractionated radiotherapy (hRT) following by surgery. The remain viable cells will be analyzed and the patients whithin less than 30% will receive more 3 cycles of cT. All patients have deep high grade soft tissue sarcoma of extremity.
Detailed description
Prospective phase II non controlled study. Staging: All patients will be submitted to a local Magnetic Resonance (MR), Chest Tomography (CT) and Positron emission tomography-computed tomography (PET CT) previous to treatment. After the first cT cycle a new PET CT will be provided and one more at the end of the neoadjuvant treatment. Chemotherapy: cT neoadjuvant: Doxorubicin 75mg/m2 (cycles 1,2 and 3), and ifosfamide 9 g/m2 (cycles 1 and 3). Radiotherapy: RT 25 Gy / 5 x 500 cGy/day, beginning at Cycle 2/Day1. The surgery will be performed after 4-6 weeks from cycle 3. The remain of viable cells in surgical specimen will be analyzed and whether the the percentage value is less than 30% the patient will receive more 3 cycles of cT. A boost of RT is indicated if margins are considered R1 (microscopic positive margin).
Interventions
DRUGDoxorubicin
Doxorubicin 75mg/m2 (cycle 1,2 and 3)
DRUGIfosfamide
Ifosfamide 9 g/m2 (cycle 1 and 3)
RADIATIONradiotherapy
radiotherapy: 25 Gy / 5 x 500 cGy/day
Sponsors
AC Camargo Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18-75 years old, with non metastatic deeply high grade soft tissue sarcoma of extremities. KPS \> 70% (Karnofsky Performance Status Score)
Exclusion criteria
* Patients with rhabdomyosarcoma, neuroendocrine tumor (Pnet) and chondrosarcomas, or who have had received radiotherapy (RT) or chemotherapy (cT) previous, or recurrent tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate disease free survival after neoadjuvant treatment | 24 months | Evaluate local and distant disease free survival after the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate wound complication rates | 30 days | Evaluate if this treatment is comparable with the Institution previous results using only cT as neoadjuvant treatment (20% of wound complications). |
| Amputation rates | 30 days | Evaluate if it can be maintained the amputation rate (less than 5%) |
| cT morbidity | 6 months | Evaluate the morbidity rates related to cT scheme |
Other
| Measure | Time frame | Description |
|---|---|---|
| PET CT response | 3 months | Evaluate if the SUV (Standard uptake value) varies after first and third cycle and if it is related to survival |
Countries
Brazil
Contacts
Primary ContactAdemar Lopes, Phd
Backup ContactRanyell S Batista, Phd
Outcome results
None listed