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A multicenter randomized controlled trial for adjuvant chemotherapy in cervical cancer with residual HPV DNA following primary radiotherapy or chemoradiation

A multicenter randomized controlled trial for adjuvant chemotherapy in cervical cancer with residual HPV DNA following primary radiotherapy or chemoradiation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012655
Enrollment
Unknown
Registered
2017-09-13
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

cervical cancer

Interventions

experiment group:TP*4 cycle

Sponsors

the Second Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed, pathological confirmed cervical cancer; 2. Aged 18-70 years; 3. HPV DNA positive pretretment; 4. Local advanced Figo stage IIA2-IVA; 5. No clinical or radiological evidence of diastant metastasis at diagnosis; 6. CR at 1 month after completion of RT or CCRT; 7. Detectable HPV DNA at 1 month after completion of RT or CCRT; 8. ECOG 0 or 1; 9. Patients must have adequate organ and marrow function as defined below: leukocytes >3,000/L; absolute neutrophil count >1,500/L; platelets >100,000/L; total bilirubin 50 ml/min; 10. Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast-feeding; 2. Second primary malignancy in last 5 years (except adequately treated basal cell carcinoma of the skin); 3. More that 12 weeks after completion of primary radiotherapy; 4. Had received prior adjuvant chemotherapy; 5. Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).

Design outcomes

Primary

MeasureTime frame
Relapse free survival;

Secondary

MeasureTime frame
overall survival;local-regional failure free survival;distant failure free survival;toxicity;the influence of residual HPV DNA on survival of cervical cancer received RT or CCRT;

Countries

China

Contacts

Public ContactYanhong Wang

the Second Affiliated Hospital of Fujian Medical University

992415639@qq.com+86 18659731867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026