Trial Information

Summary: COG AOST0331: A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy- a Phase III Intergroup Study

Part 1:

You have/Your child has been asked to participate in this research study because you have/your child has osteosarcoma (a form of cancer which arises in bones) tumor that is high grade (the cells grow very fast).  The tumors must be in the legs, arms, skull or backbone and can be localized (still be in the place(s) where they started) or can have metastasized (spread to other places in the body) as long as all the tumors can be taken out with surgery.

The main purposes of this study are:

1)                   To compare standard chemotherapy with methotrexate, doxorubicin (also called Adriamycin) and cisplatin (also called Platinol-AQ) (MAP) to experimental therapy with MAP plus ifosfamide and etoposide (MAPIE) in terms of curing subjects who have a poor tumor response to MAP alone.

2)                   To compare no additional treatment after MAP to pegylated interferon alfa-2b after MAP (MAPifn) in terms of curing subjects who have a good tumor response to MAP alone.

Other purposes are to compare the different treatments in terms of side effects and quality of life.  Tumor specimens will also be collected for another laboratory study that will investigate whether there are biological differences that can help predict how tumor will respond to treatment.

If you/your child receive MAP alone, treatment on this study will last about 7 months.  If you/your child receive MAPIE, treatment will last about 10 months. If you/your child receive pegylated interferon alfa-2b, treatment will last for up to two years total, as long as you/your child do not experience unmanageable side effects or return of disease.  After treatment and active monitoring have been completed, your/your child’s medical condition will be followed indefinitely. 

Part II:

Good Response: Now that you/your child have/has finished Part 1 Induction therapy, you/your child is being asked to continue on Part 2 of the study.  You/your child are being asked to participate in this part of the research study because your/your child’s tumor had a good response to induction chemotherapy (more than 9/10ths of the tumor cells have been killed) in part 1.  The main purpose of this study is to compare standard chemotherapy with methotrexate, doxorubicin (also called Adriamycin) and cisplatin (also called Platinol-AQ) (MAP) to experimental therapy with MAP plus pegylated interferon alfa-2b (MAPifn) in terms of survival of subjects who have a good tumor response to MAP alone. Other purposes are to compare the different treatments in terms of side effects and quality of life.  Tumor specimens will also be collected for another laboratory study that will investigate whether there are biological differences that can help predict how tumors respond to treatment.  If you/your child receive MAP alone, treatment on this study will last about 7 months.  If you/your child receive pegylated interferon alfa-2b, treatment will last for up to two years total, as long as you/your child do not experience unmanageable side effects or return of disease.  After treatment and active monitoring have been completed, your/your child’s medical condition will be followed indefinitely.

Poor Response: Now that you/your child have/has finished Part 1 (Induction) of therapy you/your child is being asked to continue on Part 2 of the study. You/your child are being asked to participate in this part of the research study because your/your child’s tumor had a poor response to induction chemotherapy (less than 9/10ths of the tumor cells have been killed) in part 1.  The main purpose of this part of the study is to compare standard chemotherapy with methotrexate, doxorubicin (also called Adriamycin) and cisplatin (also called Platinol-AQ) (MAP) to experimental therapy with MAP plus ifosfamide and etoposide (MAPIE) in terms of survival of subjects who have a poor tumor response to MAP alone.  Other purposes are to compare the different treatments in terms of side effects and quality of life.  Tumor specimens will also be collected for a laboratory study that will investigate whether there are biological differences in osteosarcoma tumors that can help predict response to treatment.  If you/your child receive MAP alone, treatment on this study will last about 7 months.  If you/your child receive MAP plus ifosfamide and etoposide, treatment will last for up to 10 months, as long as you do not/your child does not experience unmanageable side effects or return of disease.  After treatment and active monitoring have been completed, your/your child’s medical condition will be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:39:57 PM