NCT02812654

Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment

The Use of Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Treatment of High-grade Extremity Soft Tissue and Non-metastatic Sarcomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: AC Camargo Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Doxorubicin	Doxorubicin 75mg/m2 (cycle 1,2 and 3)
DRUG	Ifosfamide	Ifosfamide 9 g/m2 (cycle 1 and 3)
RADIATION	radiotherapy	radiotherapy: 25 Gy / 5 x 500 cGy/day

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2016-06-24
• Last updated: 2016-06-24

Locations

1 site across 1 country: Brazil