Clinical trial · Interventional
Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer
Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial
NCT03175848CI-TRIAL-00028732unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Stage IVB | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy,radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy,radiotherapy
- description
- Lymphatic metastasis patients undergoing 2 cycles of chemotherapy(TP/TC), blood metastasis patients receiving 4 cycles of chemotherapy, then patients with therapeutic evaluation for (CR+PR+SD) will undergo the radiotherapy (external irradiation plus brachytherapy) for primary lesion area , all patients completed total 6 cycles of chemotherapy (TP/TC), and finally will determine the of treatment plans of metastasis areas based on tolerance and discuss results by MDT.
- interventionNames
- Radiation: Chemotherapy,radiotherapy
Primary outcomes (1)
- measure
- Progression-free survival time, PFS
- timeFrame
- 2 years
- description
- Progression-free survival will be evaluated
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma ) 2. KPS≥70 3. FIGO stage IVB 4. Age: 18-70 5. ECOG (Eastern Cooperative Oncology Group) : 0-2 6. The expected survival time is \>6 months 7. Chemotherapy and radiation have not been done before 8. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function) 9. Able to understand this study and have signed informed consent. Exclusion Criteria: 1. Prior hysterectomy 2. Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm 3. Patients with brain metastasis or disseminated peritoneal metastasis 4. Female in pregnancy or lactating 5. Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy) 6. History of major psychiatric disorder 7. Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct 8. Patient with any other disease or condition is a contraindication for chemoradiotherapy 9. The researchers consider the patient not appropriate to be enrolled
References
Publications (0)
Data not yet available
No reference posted for this study.