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Trial record 7 of 8 for:    "Cervical Adenocarcinoma" | "Carboplatin"

Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462397
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 19, 2007
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: carboplatin Drug: cisplatin Drug: paclitaxel Procedure: neoadjuvant therapy Radiation: brachytherapy Radiation: radiation therapy Phase 2

Detailed Description:



  • Determine the response rate, in terms of clinical or radiologic response at 12 weeks after completion of study therapy, in patients with stage IB2-IVA cervical cancer treated with neoadjuvant chemotherapy comprising dose-dense paclitaxel and carboplatin followed by radical chemoradiotherapy comprising concurrent cisplatin and radiotherapy.


  • Determine the response rate in patients treated with this neoadjuvant chemotherapy regimen.
  • Determine the toxicity of this neoadjuvant chemotherapy regimen in these patients.
  • Assess the progression-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Neoadjuvant chemotherapy: Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Chemoradiotherapy: Beginning in week 7, or as soon as blood counts recover, patients receive cisplatin IV over 1 hour on day 1. Treatment repeats weekly for 4-6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy comprising pelvic external beam radiotherapy once daily for 5½ weeks (5 weeks for patients with positive para-aortic lymph nodes) and 2 applications of high-dose rate intracavitary brachytherapy or low- or medium-dose rate brachytherapy. Patients with parametrial or pelvic sidewall disease extension also undergo external boost radiotherapy for 3 days.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Primary Outcome Measures :
  1. Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)

Secondary Outcome Measures :
  1. Response rate at the end of neoadjuvant treatment (i.e., 6 weeks after study entry)
  2. Toxicity as assessed by NCI CTCAE v3.0
  3. Progression-free survival
  4. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462397

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United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: R. Paul Symonds, MD, FRCP, FRCR    44-116-258-6296      
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Peter R. Blake, MD    44-20-7808-2581   
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Mary McCormack, MD    44-20-7380-9302      
Sponsors and Collaborators
University College London Hospitals
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Study Chair: Mary McCormack, MD University College London Hospitals

Layout table for additonal information Identifier: NCT00462397     History of Changes
Other Study ID Numbers: CDR0000540233
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
recurrent cervical cancer

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action