Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment
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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
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Condition or disease | Intervention/treatment | Phase |
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Sarcoma, Soft Tissue | Drug: Doxorubicin Drug: Ifosfamide Radiation: radiotherapy | Phase 2 |
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 |
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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.
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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 |
- Evaluate disease free survival after neoadjuvant treatment [ Time Frame: 24 months ]Evaluate local and distant disease free survival after the treatment
- 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).
- Amputation rates [ Time Frame: 30 days ]Evaluate if it can be maintained the amputation rate (less than 5%)
- cT morbidity [ Time Frame: 6 months ]Evaluate the morbidity rates related to cT scheme
- 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 |
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.

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
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 |
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 |
Principal Investigator: | Ademar Lopes, Phd | A.C.Camargo Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Sarcoma soft tissue sarcoma neoadjuvant chemotherapy neoadjuvant radiotherapy hypofractionated radiotherapy |
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 |