Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003958
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Randomized Study of Vincristine Actinomycin-D and Cyclophosphamide VAC Versus VAC Alternating With Vincristine Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma Drugs used in chemotherapy such as dactinomycin cyclophosphamide vincristine and topotecan use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma
Detailed Description:
OBJECTIVES
I Compare the early response rates failure-free survival and survival of patients with intermediate-risk rhabdomyosarcoma treated with surgery radiotherapy and vincristine dactinomycin and cyclophosphamide VAC vs VAC alternating with vincristine topotecan and cyclophosphamide
II Compare the acute and late effects of these two treatment regimens in these patients
III Determine the rate of second-look surgery in selected patients with bulk residual tumor at diagnosis ie Clinical Group III and the proportion of these that render the patient tumor free or with microscopic tumor only
IV Determine the rate of local failure in selected patients with bulk residual tumors at diagnosis ie Clinical Group III who after second-look resection have response-adjusted radiotherapy dose reduction
V Determine if preoperative radiotherapy followed by second-look surgery is feasible for selected patients with bulk residual disease ie Clinical Group III who respond poorly to induction chemotherapy
OUTLINE This is a randomized multicenter study Patients are stratified according to disease embryonal histology stage II or III Clinical Group III vs embryonal histology Clinical Group IV less than 10 years of age vs alveolar or undifferentiated sarcoma histology stage I Clinical Group I vs alveolar or undifferentiated sarcoma histology stage II or III Clinical Group II or III Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vincristine IV over 5-10 minutes once a week on weeks 0-12 15 18-24 27 30-36 and 39 Dactinomycin IV is administered over 15-20 minutes once a week on weeks 0 3 6 9 12 21 24 27 30 33 36 and 39 Cyclophosphamide IV is administered over 30-60 minutes once a week on weeks 0 3 6 9 12 15 18 21 24 27 30 33 36 and 39 After the initial 12 weeks of chemotherapy depending on tumor shrinkage patients may undergo surgery After recovery from surgery patients receive radiotherapy once a day 5 days a week during weeks 12-18 For patients receiving radiotherapy during weeks 0-6 dactinomycin is omitted during weeks 3 and 6 and administered during weeks 15 and 18 For patients receiving radiotherapy during weeks 12-18 dactinomycin is omitted during weeks 15 and 18 Patients showing an adequate response at week 24 continue chemotherapy during weeks 24-39
Patients with Clinical Group III tumors of a parameningeal site with documented evidence of intracranial extension receive radiotherapy within the first 2 weeks of the initiation of the first course of chemotherapy day 0
Patients with Clinical Group II parameningeal tumors and Clinical Group III parameningeal tumors with base of skull erosion andor cranial nerve palsy without evidence of intracranial extension receive radiotherapy on week 12 day 84 or immediately thereafter
Patients with Clinical Group IV parameningeal tumors with distant metastases receive radiotherapy to the primary site on week 12 day 84 Patients with distant metastases confined to one site may receive radiotherapy to the metastatic site concurrently with therapy to the primary site if it began within 2 weeks of the initiation of chemotherapy day 0
Arm II Patients receive treatment as in arm I except dactinomycin is replaced with topotecan IV over 15-30 minutes daily for 5 days during weeks 3 9 21 27 33 and 39
All patients receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year until hematopoietic recovery
Patients are followed every 1-2 months for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
I Compare the early response rates failure-free survival and survival of patients with intermediate-risk rhabdomyosarcoma treated with surgery radiotherapy and vincristine dactinomycin and cyclophosphamide VAC vs VAC alternating with vincristine topotecan and cyclophosphamide
II Compare the acute and late effects of these two treatment regimens in these patients
III Determine the rate of second-look surgery in selected patients with bulk residual tumor at diagnosis ie Clinical Group III and the proportion of these that render the patient tumor free or with microscopic tumor only
IV Determine the rate of local failure in selected patients with bulk residual tumors at diagnosis ie Clinical Group III who after second-look resection have response-adjusted radiotherapy dose reduction
V Determine if preoperative radiotherapy followed by second-look surgery is feasible for selected patients with bulk residual disease ie Clinical Group III who respond poorly to induction chemotherapy
OUTLINE This is a randomized multicenter study Patients are stratified according to disease embryonal histology stage II or III Clinical Group III vs embryonal histology Clinical Group IV less than 10 years of age vs alveolar or undifferentiated sarcoma histology stage I Clinical Group I vs alveolar or undifferentiated sarcoma histology stage II or III Clinical Group II or III Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vincristine IV over 5-10 minutes once a week on weeks 0-12 15 18-24 27 30-36 and 39 Dactinomycin IV is administered over 15-20 minutes once a week on weeks 0 3 6 9 12 21 24 27 30 33 36 and 39 Cyclophosphamide IV is administered over 30-60 minutes once a week on weeks 0 3 6 9 12 15 18 21 24 27 30 33 36 and 39 After the initial 12 weeks of chemotherapy depending on tumor shrinkage patients may undergo surgery After recovery from surgery patients receive radiotherapy once a day 5 days a week during weeks 12-18 For patients receiving radiotherapy during weeks 0-6 dactinomycin is omitted during weeks 3 and 6 and administered during weeks 15 and 18 For patients receiving radiotherapy during weeks 12-18 dactinomycin is omitted during weeks 15 and 18 Patients showing an adequate response at week 24 continue chemotherapy during weeks 24-39
Patients with Clinical Group III tumors of a parameningeal site with documented evidence of intracranial extension receive radiotherapy within the first 2 weeks of the initiation of the first course of chemotherapy day 0
Patients with Clinical Group II parameningeal tumors and Clinical Group III parameningeal tumors with base of skull erosion andor cranial nerve palsy without evidence of intracranial extension receive radiotherapy on week 12 day 84 or immediately thereafter
Patients with Clinical Group IV parameningeal tumors with distant metastases receive radiotherapy to the primary site on week 12 day 84 Patients with distant metastases confined to one site may receive radiotherapy to the metastatic site concurrently with therapy to the primary site if it began within 2 weeks of the initiation of chemotherapy day 0
Arm II Patients receive treatment as in arm I except dactinomycin is replaced with topotecan IV over 15-30 minutes daily for 5 days during weeks 3 9 21 27 33 and 39
All patients receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year until hematopoietic recovery
Patients are followed every 1-2 months for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | Childrens Cancer Group | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-02302 | REGISTRY | None | None |
| IRS-D9803 | OTHER | None | None |
| COG-D9803 | OTHER | None | None |
| POG-D9803 | OTHER | None | None |
| CDR0000067157 | OTHER | None | None |
| CCG-D9803 | OTHER | None | None |