Clinical trial · Interventional
A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)
Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
- 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)
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemotherapy | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Lymph Node Metastases | — | UNRESOLVED | — |
| Radiation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiation | Radiation | — | UNRESOLVED |
| Paclitaxel, Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The control group (Group A)
- description
- In Group A, observation is given after chemoradiation
- interventionNames
- Radiation: chemoradiation
- type
- EXPERIMENTAL
- label
- The experiment group (Group B)
- description
- in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.
- interventionNames
- Radiation: chemoradiation
- Drug: Paclitaxel, Cisplatin
Primary outcomes (1)
- measure
- 3-year progression-free survival (3y-PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically diagnosed cervical cancer; 2. pelvic or para-aortic lymph metastases, at least match one of following * CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane * pelvic or para-aortic lymph node shows necrosis or extra capsular spread * PET/CT scan finds positive pelvic or para-aortic node lymph node * biopsy confirms lymph metastase 3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before; 4. Karnofsky Performance Scores ≥ 70; Exclusion Criteria: 1. Patients with distant metastasis before or during radiotherapy 2. Severe dysfunction of heart, lung, liver, kidney or hematopoietic system 3. Severe neurological, mental or endocrine diseases 4. History of other malignancies 5. Those who are considered by the researchers unsuitable to participate -
References
Publications (0)
Data not yet available