NCT04409860RecruitingNot Applicable
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Chongqing University Cancer Hospital1 site in 1 country120 target enrollmentStarted: May 26, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- PFS
Study Overview
Brief Summary
The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.
Detailed Description
- Objective:
To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT. 2. Patients:
- Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B 点 50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）
- MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
- Methods:
The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- •Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B 点 50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
- •MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
- •Expected survival is longer than six months
- •Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
- •ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
- •The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
Exclusion Criteria
- •Activity or uncontrol severe infection
- •Liver cirrhosis, Decompensated liver disease
- •History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
- •Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
- •Have suffered or combined with other malignant tumor
- •Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- •A history targeted therapy or pelvic artery embolization
- •Artery-enous thrombosis within 6 months
- •Patients with autoimmune diseases
- •Complications, need to be treatment with drugs which may lead to liver or kidney injury
- •Patients with disease progression after chemoradiation
Arms & Interventions
control group
Active Comparator
In this group, observation is given after CCRT.
Intervention: CCRT (Radiation)
trial group
Experimental
In this group, adjuvant chemotherapy is given after CCRT.
Intervention: CCRT (Radiation)
trial group
Experimental
In this group, adjuvant chemotherapy is given after CCRT.
Intervention: Paclitaxel, Cisplatin (Drug)
Outcomes
Primary Outcomes
PFS
Time Frame: 2 years
Progression-free survival
Secondary Outcomes
- ORR(3 months)
- OS(5 years)
Investigators
Dongling Zou
Associated Director
Chongqing University Cancer Hospital
Study Sites (1)
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