NCT00462397

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
Last Updated

August 26, 2013

Status Verified

April 1, 2007

First QC Date

April 18, 2007

Last Update Submit

August 23, 2013

Conditions

Cervical Cancer

Keywords

cervical adenocarcinomacervical adenosquamous cell carcinomacervical squamous cell carcinomastage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancerstage IVA cervical cancerrecurrent cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)

Secondary Outcomes (4)

  • 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

  • Overall survival

Interventions

carboplatinDRUG
cisplatinDRUG
paclitaxelDRUG
neoadjuvant therapyPROCEDURE
brachytherapyRADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

RECRUITING

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CarboplatinCisplatinPaclitaxelNeoadjuvant TherapyBrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCombined Modality TherapyTherapeutics

Study Officials

  • Mary McCormack, MD

    University College London Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

June 1, 2005

Last Updated

August 26, 2013

Record last verified: 2007-04

Locations

GB(3)