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| ID | Type | Description | Link |
|---|---|---|---|
| UCLCTC-BRD/05/22-CERVIX | |||
| EUDRACT-2005-000134-20 | |||
| CRUK-BRD/05/22 | |||
| EU-20720 | |||
| UCLCTC-CERVIX |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| paclitaxel | Drug | |||
| neoadjuvant therapy | Procedure | |||
| brachytherapy | Radiation | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate at the end of neoadjuvant treatment (i.e., 6 weeks after study entry) | ||
| Toxicity as assessed by NCI CTCAE v3.0 | ||
| Progression-free survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
Locally advanced disease (i.e., FIGO stage IB2-IVA disease)
Disease suitable for treatment with radical intent using chemoradiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mary McCormack, MD | University College London Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester Royal Infirmary | Recruiting | Leicester | England | LE1 5WW | United Kingdom |
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| Overall survival |
| Royal Marsden - London | Recruiting | London | England | SW3 6JJ | United Kingdom |
|
| University College of London Hospitals | Recruiting | London | England | WIT 3AA | United Kingdom |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D020360 | Neoadjuvant Therapy |
| D001918 | Brachytherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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