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Phase II study for concurrent chemoradiotherapy combined with consolidation chemotherapy for cervical cancer with para-aortic lymph node metastasis.

Phase II study for concurrent chemoradiotherapy combined with consolidation chemotherapy for cervical cancer with para-aortic lymph node metastasis.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020654
Enrollment
Unknown
Registered
2019-01-12
Start date
2018-11-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Cervical cancer

Interventions

Case series:4-6 cycles of consolidation chemotherapy

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. voluntarily as the subject, sign the informed consent; 2. patients aged 18-65 years; 3. pathologic tissues were clearly diagnosed as cervical cancer,unoperated advanced cervical cancer with paraventral lymph node metastasis; 4. physical condition score is 0, 1 and 2; 5. invasive cervical squamous cell carcinoma, adenocarcinoma, or adenocarcinoma confirmed by biopsy; 6. FIGO stage IB-IIA stage; 7. detection of bone marrow, liver function and renal function: (1) bone marrow function WBC is greater than or equal to 3.5 x 10^9/L; Neutrophilic granulocytes are greater than or equal to 1.5 x 10^9/L; Platelets are greater than or equal to 100x 10^9/L. Hemoglobin greater than or equal to 100 g/L (acceptable with blood transfusion or other methods); (2) the liver function was in the normal range: alanine aminotransferase (ALT), aspartate aminotransferase (AST) 60ml /min; Calculation formula: CCr=(140-age) x weight (kg)/[72 x Scr(mg/dl)] or CCr=[(140-age) x weight (kg)]/[0.818 x Scr(umol/L)]; (4) the original international ratio of thrombin (INR) is less than or equal to 1.5.

Exclusion criteria

Exclusion criteria: (1) women during pregnancy and lactation; (2) patients who are allergic to platinum drugs; (3) a history of other malignant tumors; (4) abnormal blood routine: neutrophil < 1.5x10^9/L, HB <80g/L, PLT< 80x10^9/L; Abnormal liver function: transaminase was 2 times higher than normal; Renal function, urine routine and ecg abnormality; (5) participating in other clinical trials; (6) have had systemic chemotherapy in the last 3 years; (7) there has been a history of pelvic or abdominal radiotherapy before, which may cause the irradiation field overlapping; (8) there are distant metastatic lesions in other organs; (9) there are the following severe active concomitant diseases: edema has unstable angina or/and congestive heart failure requiring hospitalization in the past 6 months;Injection occurred in the last 6 months during a transmural myocardial infarction;Severe arteriosclerosis and hypertension;An acute bacterial or fungal infection at the time of registration requires intravenous antibiotic therapy;Chronic obstructive pulmonary disease or other respiratory diseases should be treated in the hospital or in the way of research.Liver dysfunction leads to jaundice or coagulation disorders and serious renal insufficiency;Patients with severe mental disorders;Severe haematopoietic system disease;Acquired immunodeficiency disease (HIV testing is denied to patients who have been diagnosed with or suspected to have HIV);Other immunocompromised (e.g., organ transplantation, long-term use of glucocorticoids); (10) other participants were deemed unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
Disease-free progression survival (PFS);Overall survival (OS);Recent adverse reactions;

Secondary

MeasureTime frame
Tumor progression time (TTP);Long-term toxic and side effects;

Countries

China

Contacts

Public ContactFang Zhou

Yantai Yuhuangding Hospital

fangzhoustar@126.com+86 18653540841

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026