NCT04409860 The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
| NCT ID | NCT04409860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chongqing University Cancer Hospital |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-05-26 |
| Primary Completion | 2024-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2020-05-26 with a primary completion date of 2024-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 4. ECOG\<2 5. Expected survival is longer than six months 6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L 7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN 8. 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: 1. Activity or uncontrol severe infection 2. Liver cirrhosis, Decompensated liver disease 3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease 4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure 5. Have suffered or combined with other malignant tumor 6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 7. A history targeted therapy or pelvic artery embolization 8. Artery-enous thrombosis within 6 months 9. Patients with autoimmune diseases 10. Complications, need to be treatment with drugs which may lead to liver or kidney injury 11. Patients with disease progression after chemoradiation
Contact & Investigator
Dongling Zou, M.D.
PRINCIPAL INVESTIGATOR
Chongqing University Cancer Hospital
Frequently Asked Questions
Who can join the NCT04409860 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04409860 currently recruiting?
Yes, NCT04409860 is actively recruiting participants. Contact the research team at cqzl_zdl@163.com for enrollment information.
Where is the NCT04409860 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT04409860 clinical trial?
NCT04409860 is sponsored by Chongqing University Cancer Hospital. The principal investigator is Dongling Zou, M.D. at Chongqing University Cancer Hospital. The trial plans to enroll 120 participants.
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