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Zoledronate-Ostéosarcome Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant


Phase 3
5 Years
50 Years
Open (Enrolling)
Both
Sarcoma

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Trial Information

Zoledronate-Ostéosarcome Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant


OBJECTIVES:

Primary

- Compare the progression-free survival of patients with osteosarcoma treated with
combination chemotherapy with or without zoledronic acid.

Secondary

- Compare the overall survival of patients treated with these regimens.

- Compare the percentage of patients with a good histologic response.

- Compare the long and short term toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(< 18 years vs 18-25 years vs > 25 years), risk group (nonmetastatic or resectable vs
metastatic or unresectable), and treatment center. Patients receive either
methotrexate-based chemotherapy or doxorubicin hydrochloride-based chemotherapy according to
age.

- Methotrexate-based chemotherapy (patients ≤ 25 years of age): Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive methotrexate IV in weeks 1-3, 7, 8, 12, and 13 and
etoposide IV and ifosfamide IV in weeks 4 and 9.

- Arm II: Patients receive methotrexate, etoposide, and ifosfamide as in arm I.
Patients also receive zoledronic acid IV in weeks 1, 5, 9, and 13.

All patients undergo surgery in week 14. After surgery, patients are assigned to 1 of 2
groups for further treatment, based on histological response.

- Good responders (< 10% viable cells): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive methotrexate IV in weeks 1-3, 7-9, 13-15, and 19-21 and
etoposide IV in weeks 4 and 10. Patients also receive ifosfamide IV in weeks 4,
10, and 16.

- Arm II: Patients receive methotrexate, etoposide, and ifosfamide as in arm I.
Patients also receive zoledronic acid IV in weeks 3, 7, 11, 15, 19, and 23.

- Bad responders (> 10% viable cells): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive methotrexate IV in weeks 1, 5, 9, 13, and 17 and
doxorubicin hydrochloride IV and cisplatin IV in weeks 2, 6, 10, 14, and 18.

- Arm II: Patients receive methotrexate, doxorubicin hydrochloride, and cisplatin as
in arm I. Patients also receive zoledronic acid IV as in arm II (good responders).

- Doxorubicin hydrochloride-based chemotherapy (patients ≥ 18 years of age):
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive doxorubicin hydrochloride IV and ifosfamide hydrochloride IV in
weeks 1, 4, 7, 10, and 13 and cisplatin IV in weeks 1, 7, and 13.

- Arm II: Patients receive doxorubicin hydrochloride, ifosfamide, and cisplatin as in arm
I. Patients also receive zoledronic acid IV in weeks 1, 5, 9, and 13.

All patients undergo surgery in week 16. After surgery, patients are assigned to 1 of 2
groups for further treatment, based on histological response.

- Good responders (< 10% viable cells): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive doxorubicin hydrochloride IV in weeks 1 and 7 and
ifosfamide IV in weeks 1, 4, 7, and 10.

- Arm II: Patients receive doxorubicin hydrochloride and ifosfamide as in arm I.
Patients also receive zoledronic acid IV in weeks 1, 5, 9, 13, 17, and 21.

- Bad responders (> 10% viable cells):

- Arm I: Patients receive etoposide IV and ifosfamide IV in weeks 1, 4, 7, 10, and
13.

- Arm II: Patients receive etoposide and ifosfamide as in arm I. Patients also
receive zoledronic acid as in arm II (good responders).

PROJECTED ACCRUAL: A total of 440 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed high-grade osteosarcoma

- The following are excluded:

- Low-grade osteosarcoma

- Small cell osteosarcoma

- Maxillary osteosarcoma

- Primary resected osteosarcoma

- Osteosarcoma with multiple metastases for which complete removal is not feasible
even after shrinkage with chemotherapy

- Extra-osseous osteosarcoma

- Any prior osteonecrosis of the maxilla

PATIENT CHARACTERISTICS:

- Bilirubin ≤ 2 times upper limit of normal

- No medical condition that would preclude study treatment

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Shortening fraction ≥ 28%

- LVEF ≥ 50%

- Glomerular filtration rate ≥ 70mL/min

- No recent dental problem, including infection, traumatization, or surgery

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Laurence Brugieres, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

Unspecified

Study ID:

CDR0000543987

NCT ID:

NCT00470223

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Sarcoma
  • localized osteosarcoma
  • metastatic osteosarcoma
  • Osteosarcoma
  • Sarcoma

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