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Sarcoma, Soft TissuePhase 2NCT02812654

Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment

A Phase 2 study testing Doxorubicin, Ifosfamide and radiotherapy in people with Sarcoma, Soft Tissue, run by AC Camargo Cancer Center at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Doxorubicin, Ifosfamide and radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteBrazil
Study dates
Mar 2015to Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 18-75 years old, with non metastatic deeply high grade soft tissue sarcoma of extremities. KPS > 70% (Karnofsky Performance Status Score)

Who cannot join

  • Patients with rhabdomyosarcoma, neuroendocrine tumor (Pnet) and chondrosarcomas, or who have had received radiotherapy (RT) or chemotherapy (cT) previous, or recurrent tumors.

Trial locations and contacts

1 site in 1 country.

Ademar Lopes, Phd contact

55-11-2189-5000 ext. 2304

ademar-lopes@uol.com.br

Ranyell S Batista, Phd contact

55-11-2189-5000 ext. 2304

ranyell.spencer@gmail.com

Brazil1 site, 1 recruiting

  • A.C.Camargo Cancer Center

    São Paulo, São Paulo, CEP 01509 - 010

    Bruna C Kupper, Nurse, 55-11-21895000 ext. 2946, bruna.sousa@accamargo.org.br

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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).

Being tested
Doxorubicin, Ifosfamide, radiotherapy
Keywords
Sarcoma, soft tissue sarcoma, neoadjuvant chemotherapy, neoadjuvant radiotherapy, hypofractionated radiotherapy
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

    Also called Adriamycin

    Doxorubicin 75mg/m2 (cycle 1,2 and 3)

  • IfosfamideDrug

    Also called Mitoxana

    Ifosfamide 9 g/m2 (cycle 1 and 3)

  • radiotherapyRadiation

    radiotherapy: 25 Gy / 5 x 500 cGy/day

Study groups in NCT02812654
Study groupRoleWhat they receive
Doxorubicin, Ifosfamide, radiotherapyExperimentalDoxorubicin 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.
Receives: Drug: Doxorubicin; Drug: Ifosfamide; Radiation: radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate disease free survival after neoadjuvant treatment

    Evaluate local and distant disease free survival after the treatment

    Measured: 24 months

Secondary outcomes (3)

  1. Evaluate wound complication rates

    Evaluate if this treatment is comparable with the Institution previous results using only cT as neoadjuvant treatment (20% of wound complications).

    Measured: 30 days

  2. Amputation rates

    Evaluate if it can be maintained the amputation rate (less than 5%)

    Measured: 30 days

  3. cT morbidity

    Evaluate the morbidity rates related to cT scheme

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02812654
Sponsor's protocol ID
1947/14
Status last verified
Mar 2016
First submitted
24 Mar 2016
Last updated
24 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Aguiar Junior S, Ferreira Fde O, Rossi BM, Santos EM, Salvajoli JV, Lopes A. Neoadjuvant chemoradiation therapy for soft tissue sarcomas of the extremities. Clinics (Sao Paulo). 2009;64(11):1059-64. doi: 10.1590/S1807-59322009001100005.

    PubMed 19936179

  • Aguiar S Jr, da Cunha IW, Lopes A. Genomic expression, chemotherapy response, and molecular targets in soft tissue sarcomas of the extremities: promising strategies for treatment selection. J Surg Oncol. 2010 Jan 1;101(1):92-6. doi: 10.1002/jso.21422.

    PubMed 19834919

  • Benz MR, Czernin J, Allen-Auerbach MS, Tap WD, Dry SM, Elashoff D, Chow K, Evilevitch V, Eckardt JJ, Phelps ME, Weber WA, Eilber FC. FDG-PET/CT imaging predicts histopathologic treatment responses after the initial cycle of neoadjuvant chemotherapy in high-grade soft-tissue sarcomas. Clin Cancer Res. 2009 Apr 15;15(8):2856-63. doi: 10.1158/1078-0432.CCR-08-2537. Epub 2009 Apr 7.

    PubMed 19351756

  • Cormier JN, Huang X, Xing Y, Thall PF, Wang X, Benjamin RS, Pollock RE, Antonescu CR, Maki RG, Brennan MF, Pisters PW. Cohort analysis of patients with localized, high-risk, extremity soft tissue sarcoma treated at two cancer centers: chemotherapy-associated outcomes. J Clin Oncol. 2004 Nov 15;22(22):4567-74. doi: 10.1200/JCO.2004.02.057.

    PubMed 15542808

  • Eilber FC, Rosen G, Nelson SD, Selch M, Dorey F, Eckardt J, Eilber FR. High-grade extremity soft tissue sarcomas: factors predictive of local recurrence and its effect on morbidity and mortality. Ann Surg. 2003 Feb;237(2):218-26. doi: 10.1097/01.SLA.0000048448.56448.70.

    PubMed 12560780

  • Freedman GM. Hypofractionated radiation therapy in the treatment of early-stage breast cancer. Curr Oncol Rep. 2012 Feb;14(1):12-9. doi: 10.1007/s11912-011-0207-7.

    PubMed 22071682

  • Grobmyer SR, Maki RG, Demetri GD, Mazumdar M, Riedel E, Brennan MF, Singer S. Neo-adjuvant chemotherapy for primary high-grade extremity soft tissue sarcoma. Ann Oncol. 2004 Nov;15(11):1667-72. doi: 10.1093/annonc/mdh431.

    PubMed 15520069

  • Gronchi A, Frustaci S, Mercuri M, Martin J, Lopez-Pousa A, Verderio P, Mariani L, Valagussa P, Miceli R, Stacchiotti S, Dei Tos AP, De Paoli A, Longhi A, Poveda A, Quagliuolo V, Comandone A, Casali PG, Picci P. Short, full-dose adjuvant chemotherapy in high-risk adult soft tissue sarcomas: a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group. J Clin Oncol. 2012 Mar 10;30(8):850-6. doi: 10.1200/JCO.2011.37.7218. Epub 2012 Feb 6.

    PubMed 22312103

  • Gobo Silva ML, Lopes de Mello CA, Aguiar Junior S, D'Almeida Costa F, Stevanato Filho PR, Santoro Bezerra T, Nakagawa SA, Nascimento AG, Werneck da Cunha I, Spencer Sobreira Batista RM, Nicolau Daher UR, Da Cruz Formiga MN, Germano JN, Catin Kupper BE, De Assis Pellizzon AC, Lopes A. Neoadjuvant hypofractionated radiotherapy and chemotherapy for extremity soft tissue sarcomas: Safety, feasibility, and early oncologic outcomes of a phase 2 trial. Radiother Oncol. 2021 Jun;159:161-167. doi: 10.1016/j.radonc.2021.03.033. Epub 2021 Mar 31.

    PubMed 33798613

  • Spencer RM, Aguiar Junior S, Ferreira FO, Stevanato Filho PR, Kupper BE, Silva ML, Mello CA, Bezerra TS, Lopes A. Neoadjuvant Hypofractionated Radiotherapy and Chemotherapy in High-Grade Extremity Soft Tissue Sarcomas: Phase 2 Clinical Trial Protocol. JMIR Res Protoc. 2017 May 25;6(5):e97. doi: 10.2196/resprot.6806.

    PubMed 28546135

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin, Ifosfamide and radiotherapy in people with Sarcoma, Soft Tissue, run by AC Camargo Cancer Center at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ademar Lopes, Phd (55-11-2189-5000 ext. 2304, ademar-lopes@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate disease free survival after neoadjuvant treatment (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02812654, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.

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