Status:
UNKNOWN
Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade, Operable, Non-metastatic Osteosarcoma of the Extremity
Lead Sponsor:
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Conditions:
High Grade Osteosarcoma
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
Brief Summary
Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of maintenance therapy...
Detailed Description
The study design includes a backbone of 10 weeks of preoperative therapy using MAP (High-dose methotrexate, cisplatin, and doxorubicin). Following surgery, non-metastatic patients were randomized by b...
Eligibility Criteria
Inclusion
- Patients with high-grade malignancy osteosarcoma , biopsy-proven , newly diagnosed , previously untreated . Patients with osteosarcoma as a second malignancy should also be eligible .
- Patients with any primary site , with or without metastases at diagnosis , will be accepted and treated.
- Patients \< 30 years.
- Patients must have normal body function and adequate renal function defined as serum creatinine \< 1.5 x the normal value or creatinine clearance \> 60ml/min/1 ,73m2 .
- Patients must have adequate hepatic function, defined as total bilirubin \< 1.5 x normal, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 2.5 x normal.
- Patients must have adequate cardiac function defined by a shortening fraction \> 27 % by echocardiogram or ejection fraction \> 47 % by radioisotopic angiogram .
- If pre- chemotherapy amputation is necessary, the patient is included in the study and eligible to survival analyzes, however the pathological analyze response will be not performed.
- Obtain material for pathological and molecular study is recommended .
- Whenever possible a central catheter should be placed against the intensity of chemotherapy and need for forced hydration .
- Patient or legal guardian must sign a consent form which will be explain the type of treatment and procedures that the patient will be submitted .
- Time \> than 4 weeks between biopsy and initiation of treatment - Restaging
Exclusion
- Disease progression ( increase of at least 20% of the extent of the lesion, taking as reference the smallest measurement recorded from the start of treatment, or the appearance of one or more lesions );
- Any properly documented clinical situation , which at the discretion of the attending physician , patient can not follow with chemotherapy , for safety reasons ;
- The evaluation of cardiac aspects will be done carefully , so will exclude patients with 20% reduction in the ejection fraction of the left ventricle compared to baseline or with a ventricular ejection fraction \< 45 % regardless of baseline;
- The patient refusal to continue treatment ;
- Nephrotoxicity , neurotoxicity and ototoxicity grade 4 ;
- Delay greater than 40 days for the realization of the next treatment cycle , not related to toxicity;
- Refusal of surgery ; 8 . Variation above 20% of the recommended dose without justification.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT02273583
Start Date
May 1 2006
Last Update
February 11 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GRAACC- Institute of Pediatric Oncology
São Paulo, São Paulo, Brazil, 04023-062