Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262821
Status:
TERMINATED
Last Update Posted:
2019-07-23
First Post:
2005-12-06
Brief Title:
Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2 IIA IIIB and IVA Cervical Carcinoma Limited to the Pelvis
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study drug no longer available resulting in lack of study drug for participants
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 studying cisplatin radiation therapy and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer Drugs used in chemotherapy such as cisplatin and tirapazamine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer
Detailed Description:
PRIMARY OBJECTIVE
I Compare the progression-free survival of patients with stage IB IIA IIB IIIB or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine
SECONDARY OBJECTIVES
I Compare overall survival of patients treated with these regimens II Compare the toxicity of these regimens in these patients
TERTIARY OBJECTIVES
I Correlate study treatment with tumor expression of carbonic anhydrase IX CA-IX and recurrence-free survival overall survival or metastasis in patients treated with these regimens
II Correlate expression of CA-IX hypoxia inducible factor-1α CD-31 thrombospondin-1 CD-105 or vascular endothelial growth factor VEGF in primary tumor tissue with recurrence-free survival overall survival or metastasis in patients treated with these regimens
III Correlate pre-treatment andor post-treatment serum concentrations of angiogenic markers including angiogenin or VEGF with recurrence-free survival overall survival or metastasis in patients treated with these regimens
IV Correlate various combinations of biological markers of hypoxia and angiogenesis with recurrence-free survival overall survival or metastasis in patients treated with these regimens
V Correlate levels of individual biological markers of hypoxia or angiogenesis with clinicopathological characteristics including tumor size histologic subtype FIGO stage depth of invasion pelvic node status site of recurrence and hemoglobin level as well as patient age race and performance status in patients treated with these regimens
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to FIGO stage of disease IB2 vs IIA vs IIB vs IIIB vs IVA brachytherapy method low-dose rate vs high-dose rate surgical staging of para-aortic nodes yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive cisplatin IV over 30-60 minutes once weekly on days 1 8 15 22 29 and 36 weeks 1-6 Patients also undergo external beam radiotherapy to the pelvis once daily on days 1-5 8-12 15-19 22-26 and 29-33 weeks 1-5 Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate HDR brachytherapy once weekly in weeks 4-8 and 3-5 days of parametrial boost radiotherapy beginning after the first brachytherapy implant Treatment continues in the absence of disease progression or unacceptable toxicity
ARM II Patients receive tirapazamine IV over 2 hours on days 1 8 10 12 15 22 24 26 and 29 and cisplatin IV over 1 hour on days 1 15 and 29 Patients also undergo radiotherapy and brachytherapy as in arm I Treatment continues in the absence of disease progression or unacceptable toxicity
NOTE No external beam radiotherapy is administered on the day of HDR brachytherapy If the majority of external beam radiotherapy has been administered HDR brachytherapy may be administered in 2 applications per week separated by at least 72 hours in order to complete all treatment within 8 weeks
NOTE Patients may receive a parametrial boost at the discretion of the treating radiation oncologist
After completion of study treatment patients are followed for at least 5 years
I Compare the progression-free survival of patients with stage IB IIA IIB IIIB or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine
SECONDARY OBJECTIVES
I Compare overall survival of patients treated with these regimens II Compare the toxicity of these regimens in these patients
TERTIARY OBJECTIVES
I Correlate study treatment with tumor expression of carbonic anhydrase IX CA-IX and recurrence-free survival overall survival or metastasis in patients treated with these regimens
II Correlate expression of CA-IX hypoxia inducible factor-1α CD-31 thrombospondin-1 CD-105 or vascular endothelial growth factor VEGF in primary tumor tissue with recurrence-free survival overall survival or metastasis in patients treated with these regimens
III Correlate pre-treatment andor post-treatment serum concentrations of angiogenic markers including angiogenin or VEGF with recurrence-free survival overall survival or metastasis in patients treated with these regimens
IV Correlate various combinations of biological markers of hypoxia and angiogenesis with recurrence-free survival overall survival or metastasis in patients treated with these regimens
V Correlate levels of individual biological markers of hypoxia or angiogenesis with clinicopathological characteristics including tumor size histologic subtype FIGO stage depth of invasion pelvic node status site of recurrence and hemoglobin level as well as patient age race and performance status in patients treated with these regimens
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to FIGO stage of disease IB2 vs IIA vs IIB vs IIIB vs IVA brachytherapy method low-dose rate vs high-dose rate surgical staging of para-aortic nodes yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive cisplatin IV over 30-60 minutes once weekly on days 1 8 15 22 29 and 36 weeks 1-6 Patients also undergo external beam radiotherapy to the pelvis once daily on days 1-5 8-12 15-19 22-26 and 29-33 weeks 1-5 Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate HDR brachytherapy once weekly in weeks 4-8 and 3-5 days of parametrial boost radiotherapy beginning after the first brachytherapy implant Treatment continues in the absence of disease progression or unacceptable toxicity
ARM II Patients receive tirapazamine IV over 2 hours on days 1 8 10 12 15 22 24 26 and 29 and cisplatin IV over 1 hour on days 1 15 and 29 Patients also undergo radiotherapy and brachytherapy as in arm I Treatment continues in the absence of disease progression or unacceptable toxicity
NOTE No external beam radiotherapy is administered on the day of HDR brachytherapy If the majority of external beam radiotherapy has been administered HDR brachytherapy may be administered in 2 applications per week separated by at least 72 hours in order to complete all treatment within 8 weeks
NOTE Patients may receive a parametrial boost at the discretion of the treating radiation oncologist
After completion of study treatment patients are followed for at least 5 years
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 |
|---|---|---|---|
| NCI-2009-00591 | REGISTRY | None | None |
| CAN-NCIC-GOG-0219 | None | None | None |
| CDR0000455555 | None | None | None |
| GOG-0219 | OTHER | None | None |
| GOG-0219 | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |