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Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812654
Recruitment Status : Unknown
Verified March 2016 by AC Camargo Cancer Center.
Recruitment status was:  Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
AC Camargo Cancer Center

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.

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Doxorubicin Drug: Ifosfamide Radiation: radiotherapy Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Treatment of High-grade Extremity Soft Tissue and Non-metastatic Sarcomas
Study Start Date : March 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: Doxorubicin, Ifosfamide, radiotherapy
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.
Drug: Doxorubicin
Doxorubicin 75mg/m2 (cycle 1,2 and 3)
Other Name: Adriamycin

Drug: Ifosfamide
Ifosfamide 9 g/m2 (cycle 1 and 3)
Other Name: Mitoxana

Radiation: radiotherapy
radiotherapy: 25 Gy / 5 x 500 cGy/day




Primary Outcome Measures :
  1. Evaluate disease free survival after neoadjuvant treatment [ Time Frame: 24 months ]
    Evaluate local and distant disease free survival after the treatment


Secondary Outcome Measures :
  1. Evaluate wound complication rates [ Time Frame: 30 days ]
    Evaluate if this treatment is comparable with the Institution previous results using only cT as neoadjuvant treatment (20% of wound complications).

  2. Amputation rates [ Time Frame: 30 days ]
    Evaluate if it can be maintained the amputation rate (less than 5%)

  3. cT morbidity [ Time Frame: 6 months ]
    Evaluate the morbidity rates related to cT scheme


Other Outcome Measures:
  1. PET CT response [ Time Frame: 3 months ]
    Evaluate if the SUV (Standard uptake value) varies after first and third cycle and if it is related to survival



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812654


Contacts
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Contact: Ademar Lopes, Phd 55-11-2189-5000 ext 2304 ademar-lopes@uol.com.br
Contact: Ranyell S Batista, Phd 55-11-2189-5000 ext 2304 ranyell.spencer@gmail.com

Locations
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Brazil
A.C.Camargo Cancer Center Recruiting
São Paulo, Sao Paulo, Brazil, CEP 01509 - 010
Contact: Bruna C Kupper, Nurse    55-11-21895000 ext 2946    bruna.sousa@accamargo.org.br   
Sponsors and Collaborators
AC Camargo Cancer Center
Investigators
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Principal Investigator: Ademar Lopes, Phd A.C.Camargo Cancer Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT02812654    
Other Study ID Numbers: 1947/14
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by AC Camargo Cancer Center:
Sarcoma
soft tissue sarcoma
neoadjuvant chemotherapy
neoadjuvant radiotherapy
hypofractionated radiotherapy
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents