Induction Chemotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
Study Details
Study Description
Brief Summary
The main objective of this study is to determine whether neoadjuvant chemotherapy with cisplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves progression free survival rates compared to chemoradiation therapy alone in locally advanced cervical cancer.
Women in the experimental arm will receive neoadjuvant chemotherapy with cisplatin and paclitaxel 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: NACT+CCRT Patients will be treated with 2 cycles of neoadjuvant chemotherapy (Cisplatin 50 mg/m^2 d2 q 21+ Paclitaxel 135 mg/m^2 d1 q 21). After that, weekly cisplatin 30mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50Gy) in 1.8 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 brachytherapy, with an additional 30-40 Gy using either image guidance or to point A (in low dose-rate equivalent dose), for a total point A dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. |
Drug: NACT
Cisplatin 50 mg/m^2 d2 q 21+ Paclitaxel 135 mg/m^2 d1 q 21
Other Names:
Radiation: CCRT
external beam radiotherapy (EBRT) concomitant with weekly cisplatin 30mg/m2
Other Names:
Radiation: Brachytherapy
The primary cervical tumor is the boosted, using brachytherapy, with an additional 30-40 Gy using either image guidance or to point A (in low dose-rate equivalent dose), for a total point A dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors.
|
| Experimental: Experimental: CCRT alone weekly cisplatin 30mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50Gy) in 1.8 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 brachytherapy, with an additional 30-40 Gy using either image guidance or to point A (in low dose-rate equivalent dose), for a total point A dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. |
Radiation: CCRT
external beam radiotherapy (EBRT) concomitant with weekly cisplatin 30mg/m2
Other Names:
Radiation: Brachytherapy
The primary cervical tumor is the boosted, using brachytherapy, with an additional 30-40 Gy using either image guidance or to point A (in low dose-rate equivalent dose), for a total point A dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors.
|
Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) [Up to approximately 36 months]
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.
Secondary Outcome Measures
- Overall Survival (OS) [Up to approximately 48 months]
OS is the time from randomization to death due to any cause.
- Objective Response Rate (ORR) [Up to approximately 36 months]
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.
- Number of Participants Who Experience One or More Adverse Events (AEs) [Up to approximately 36 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years old
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Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB3-IIIB.
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According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion
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No prior treatment
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Expected survival period ≥ 3 months
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ECOG score: 0-1
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No obvious signs of hematological diseases, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×10^9/L, and no bleeding tendency before enrollment;
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Adequate hepato-renal function is needed, including: Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min
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Patients voluntarily participated in the study and signed informed consent
Exclusion Criteria:
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Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures
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Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part
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Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases
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Active infections, HIV infections, and viral hepatitis that require systematic treatment
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Patients with≥Grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0
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Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months
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It is known to have a history of allergies to research drugs or drug components
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Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication
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Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent
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The investigator believes that the patient is not suitable for participating in this clinical research
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sicchuan cancer hospital | Chengdu | Sichuan | China | 610000 |
Sponsors and Collaborators
- Sichuan Cancer Hospital and Research Institute
Investigators
- Principal Investigator: Guonan Zhang, Sichuan Cancer Hospital and Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY-2021-109