ClinicalTrials.Veeva

Menu

Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment

A

AC Camargo Cancer Center

Status and phase

Unknown
Phase 2

Conditions

Sarcoma, Soft Tissue

Treatments

Radiation: radiotherapy
Drug: Ifosfamide
Drug: Doxorubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT02812654
1947/14

Details and patient eligibility

About

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.

Full 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).

Enrollment

70 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Doxorubicin, Ifosfamide, radiotherapy
Experimental group
Description:
Doxorubicin 75mg/m2 (cycle 1,2 and 3), ifosfamide 9 g/m2 (cycle 1 and 3) and radiotherapy: 25 Gy / 5 x 500 cGy/day, beginning at Cycle2/Day1. The surgery will performed after 4-6 weeks from cycle 3. The remain viable cells in surgical specimen will be analyzed and if it accounts less than 30% the patient will receive more 3 cycles of cT. A boost of RT is indicated if margins are considered R1.
Treatment:
Radiation: radiotherapy
Drug: Doxorubicin
Drug: Ifosfamide

Trial contacts and locations

1

Loading...

Central trial contact

Ranyell S Batista, Phd; Ademar Lopes, Phd

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems