Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04016142
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2019-05-31
Brief Title:
Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
ACCRAPAN
Brief Summary:
This is a mutlicentric open-label non-randomized national 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes
Detailed Description:
This is a mutlicentric open-label non-randomized national 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes
Patients
will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care standard concomitant radio-chemotherapy Part 1 of the study
will be included in the second part of the study for the second part of treatment experimental adjuvant chemotherapy Part 2 of the study providing they fulfill eligibility criteria at this stage no progression during Part 1 of the study and no medical contra-indication to the study treatment
The primary objective is to evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival PFS in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes
Patients
will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care standard concomitant radio-chemotherapy Part 1 of the study
will be included in the second part of the study for the second part of treatment experimental adjuvant chemotherapy Part 2 of the study providing they fulfill eligibility criteria at this stage no progression during Part 1 of the study and no medical contra-indication to the study treatment
The primary objective is to evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival PFS in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2018-001752-35 | EUDRACT_NUMBER | None | None |