Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment

NCT02812654 | Unknown Phase 2 DMC

• 1 other identifier: 1947/14
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma, Soft Tissue

Keywords

Sarcoma; soft tissue sarcoma; neoadjuvant chemotherapy; neoadjuvant radiotherapy; hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Evaluate disease free survival after neoadjuvant treatment

  Evaluate local and distant disease free survival after the treatment

  24 months

Secondary Outcomes (3)

• Evaluate wound complication rates

  30 days

• Amputation rates

  30 days

• cT morbidity

  6 months

Other Outcomes (1)

• PET CT response

  3 months

Study Arms (1)

Doxorubicin, Ifosfamide, radiotherapy

EXPERIMENTAL

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; Drug: Ifosfamide; Radiation: radiotherapy

Interventions

Doxorubicin DRUG

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

Also known as: Adriamycin

Doxorubicin, Ifosfamide, radiotherapy

Ifosfamide DRUG

Ifosfamide 9 g/m2 (cycle 1 and 3)

Also known as: Mitoxana

Doxorubicin, Ifosfamide, radiotherapy

radiotherapy RADIATION

radiotherapy: 25 Gy / 5 x 500 cGy/day

Doxorubicin, Ifosfamide, radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

A.C.Camargo Cancer Center

São Paulo, São Paulo, CEP 01509 - 010, Brazil

RECRUITING

Related Publications (10)

• 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.

  PMID: 19936179 BACKGROUND

• 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.

  PMID: 19834919 BACKGROUND

• 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.

  PMID: 19351756 BACKGROUND

• 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.

  PMID: 15542808 BACKGROUND

• 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.

  PMID: 12560780 BACKGROUND

• 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.

  PMID: 22071682 BACKGROUND

• 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.

  PMID: 15520069 BACKGROUND

• 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.

  PMID: 22312103 BACKGROUND

• 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.

  PMID: 33798613 DERIVED

• 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.

  PMID: 28546135 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin; Ifosfamide; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Ademar Lopes, Phd

  A.C.Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ademar Lopes, Phd

CONTACT

55-11-2189-5000; ademar-lopes@uol.com.br

Ranyell S Batista, Phd

CONTACT

55-11-2189-5000; ranyell.spencer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: June 24, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: June 24, 2016

Record last verified: 2016-03

Locations

BR (1)