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The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates.
Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone.
286 patients will be recruited during 2 years, with 3 years of follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Neoadjuvant Therapy+CCRT | Experimental | Patients will be treated with 2 cycles of neoadjuvant chemotherapy (Cisplatin 50 mg/m^2 d1 q21+ Paclitaxel 175 mg/m^2 d1 q21) combined with serplulimab (300mg d1 q21). After that, weekly cisplatin 30mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. All radiotherapy should be completed within eight weeks. |
|
| Experimental: CCRT alone | Experimental | weekly cisplatin 40mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. All radiotherapy should be completed within eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Therapy | Drug | Cisplatin 50 mg/m^2 d1 q21+ Paclitaxel 175 mg/m^2 d1 q21+serplulimab 300mg d1 q21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. | Up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is the time from randomization to death due to any cause. | Up to approximately 48 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guonan Zhang | Contact | 86-13881866599 | zhanggn@hotmail.com | |
| Hong Liu | Contact | 86-13693447854 | liuhaotian12@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guonan Zhang | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sicchuan cancer hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D059248 | Chemoradiotherapy |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| CCRT | Radiation | weekly cisplatin for 4 or 5 weeks is administered concomitant with EBRT (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. |
|
|
| Brachytherapy | Radiation | The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. |
|
| Up to approximately 36 months |
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 36 months |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |