Clinical trial · Interventional
Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin followed by cisplatin and radiation therapy works in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
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 | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)
Secondary outcomes (4)
- measure
- Response rate at the end of neoadjuvant treatment (i.e., 6 weeks after study entry)
- measure
- Toxicity as assessed by NCI CTCAE v3.0
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the cervix, including any of the following subtypes: * Squamous cell carcinoma * Adenocarcinoma * Adenosquamous cell carcinoma * Locally advanced disease (i.e., FIGO stage IB2-IVA disease) * Stage confirmed by examination under anesthesia, cystoscopy, and sigmoidoscopy with biopsy of any suspicious lesions in the bladder, vagina, or rectum * Disease suitable for treatment with radical intent using chemoradiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 12.5 g/dL * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Bilirubin \< 1.25 times upper limit of normal (ULN) * Glomerular filtration rate (GFR) normal by ethylenediaminetetraacetic acid (EDTA) OR creatinine clearance ≥ 60 mL/min * Placement of ureteric stents required for all patients with hydronephrosis, regardless of renal function * ALT or AST \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * No prior diagnosis of cancer, except basal cell skin cancer * No active cardiac disease * Deemed fit to receive chemoradiotherapy * ECG normal PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (0)
Data not yet available