CompletedPhase 3

Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

United States, Australia, Canada1,334 participantsStarted 2005-11-14

Plain-language summary

This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.

Who can participate

Age range

5 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed high-grade osteosarcoma, including second malignancies * Localized or metastatic disease * The primary tumor must be located in the limbs or axial skeleton, including any of the following sites\*: * Long bone of upper limb * Short bone of upper limb * Long bone of lower limb * Short bone of lower limb * Vertebral column * Ribs, sternum, clavicle, or scapula * Pelvic bones, sacrum, or coccyx * Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy * Suitable for neoadjuvant chemotherapy * Performance status - Lansky 50-100% (for patients under 16 years of age) * Performance status - Karnofsky 50-100%\* * Performance status - WHO or ECOG 0-2\* * Platelet count ≥ 100,000/mm³ * Neutrophil count ≥ 1,500/mm³ * WBC ≥ 3,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal * Creatinine clearance ≥ 70 mL/min * Creatinine based on age as follows: * No greater than 1.0 mg/dL (for patients 5 to 10 years of age) * No greater than 1.2 mg/dL (for patients 11 to 15 years of age) * No greater than 1.5 mg/dL (for patients over 15 years of age) * Ejection fraction ≥ 50% by radionuclide angiogram * Shortening fraction ≥ 28% by echocardiogram * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity * No prior chemotherapy for any disease * Prior radiotherapy for anothe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free Survival (EFS)

Timeframe: From date of randomization to date of the event.

Trial details

NCT IDNCT00134030

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2015-01-31

Results submitted2022-11-21

View on ClinicalTrials.gov More Localized Osteosarcoma trials