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A Multicenter, Randomized, Parallel Controlled Trial for Dose-dense Neo-adjuvant Chemotherapy Followed by Concurrent Chemo-Radiation (CCRT) and CCRT alone for IIB-IVA Cervical Cancer

A Multicenter, Randomized, Parallel Controlled Trial for Dose-dense Neo-adjuvant Chemotherapy Followed by Concurrent Chemo-Radiation (CCRT) and CCRT alone for IIB-IVA Cervical Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025327
Enrollment
Unknown
Registered
2019-08-24
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Interventions

Experimental group:NACT+CCRT

Sponsors

Ruijin Hospital Affiliated to Medical school of Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~70 year old; 2. Histologically confirmed squamous carcinomma, adenocarcinoma or adeno-squamous carcinoma of the cervix; 3. FIGO (2009)stage IIB-IVA as evaluated by two senior gynecological oncologists; 4. Performance status ECOG =40KG; 6. White blood cell count >=4.0x10^9/LHemoglobin >=70g/L; platelets >=100.0x10^9/L; Liver function: serum bilirubin <=1.0 N; ALT/AST <=1.0 N; ALP <=1.0 N; Renal function: BUN <=1.0 N, Cr<=1.0 N; 7. No active TB; 8. Negative pregnancy test, HCG (-); 9. Negative HIV test; 10. Capable of providing written or witnessed informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous pelvic malignant diseases with chemotherapy or radiotherapy; 2. Having received pelvic or abdominal radiotherapy; 3. Supra-renal lymph nodes metastasis or distant metastasis detected by PET-CT or chest/abdominal CT; 4. Acute infection or uncontrolled severe medical condition; 5. Pregnant or lactating; 6. Intestinal Perforation or acute ileus; 7. Uncontrolled cardiac disease (defined as a cardiac function which would preclude hydration during a cisplatin administration and any contraindication to paclitaxel); 8. Adrenocortical insufficiency; 9. Bone marrow metastasis; 10. Not meeting requirements for chemotherapy.

Design outcomes

Primary

MeasureTime frame
Disease free survival;Overall survival;2 year disease free survival;2 year overall survival;

Secondary

MeasureTime frame
Response rate after NACT;Response rate after completion of treatment;

Countries

China

Contacts

Public ContactFENG WEIWEI

Ruijin Hospital attached to Medical school of Shanghai Jiao Tong University

fww12066@rjh.com.cn+86 18917763870

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026