Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039338
Status:
UNKNOWN
Last Update Posted:
2016-12-05
First Post:
2002-06-06
Brief Title:
Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs Concomitant Radiotherapy And Chemotherapy In FIGO Ib2 IIa4 cm or IIb Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery Radiation therapy uses high-energy x-rays to kill tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer
Detailed Description:
OBJECTIVES
Compare the overall and progression-free survival of patients with stage IB2 IIA or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy
Compare the 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 participating center FIGO stage age 18 to 50 vs 51 to 75 and histological subtype adenomatous vs non-adenomatous component Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive neoadjuvant cisplatin-based chemotherapy on day 1 Treatment repeats every 21 days Within 6 weeks after the last chemotherapy course patients undergo a type III-V Piver-Rutledge radical hysterectomy Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily 5 days a week for 5-56 weeks 25-28 treatment days followed by external boost radiotherapy or brachytherapy for 1 or 2 days
Arm II Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks Adjuvant hysterectomy is allowed but not recommended in case of histologically proven residual tumor
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity For patients in both arms cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given
Quality of life is assessed at baseline and at 6 12 18 and 24 months
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 686 patients 343 per treatment arm will be accrued for this study within 38 years
Compare the overall and progression-free survival of patients with stage IB2 IIA or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy
Compare the 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 participating center FIGO stage age 18 to 50 vs 51 to 75 and histological subtype adenomatous vs non-adenomatous component Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive neoadjuvant cisplatin-based chemotherapy on day 1 Treatment repeats every 21 days Within 6 weeks after the last chemotherapy course patients undergo a type III-V Piver-Rutledge radical hysterectomy Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily 5 days a week for 5-56 weeks 25-28 treatment days followed by external boost radiotherapy or brachytherapy for 1 or 2 days
Arm II Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks Adjuvant hysterectomy is allowed but not recommended in case of histologically proven residual tumor
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity For patients in both arms cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given
Quality of life is assessed at baseline and at 6 12 18 and 24 months
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 686 patients 343 per treatment arm will be accrued for this study within 38 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 |
|---|---|---|---|
| 2008-003396-52 | EUDRACT_NUMBER | None | None |