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CompletedNCT00178269Updated May 19, 2009

Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

A Phase 2 interventional study of docetaxel and Radiation Therapy in Cervix Neoplasm, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-19.

Sponsored by University of Rochester · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated.

02

Conditions studied

  • Cervix Neoplasm
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy.
  • No evidence of para-aortic or distant metastases. Must have evaluable disease.
  • Zubrod Performance Status 0-2 or Karnofsky Performance Status > 60
  • Laboratory values must be as follows:

White blood cell count: > 3,000/mm3,Absolute granulocyte count: > 1,500/mm3, Hemoglobin > 8.0 g/dl, Platelets: > 100,000/mm3, Serum creatinine: \< 2.5 mg/dl, Serum calcium: \< 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin \< ULN for the institution,

  • Signed study-specific informed consent p
  • Age > 18 years.
  • Peripheral neuropathy must be \< grade 1.

Exclusion criteria

Exclusion Criteria:

  • Prior or simultaneous malignancies (other than skin cancer) unless disease-free
  • Medical illness preventing the use of taxane-based chemotherapy.
  • Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic.
  • Previous or current medical or psychiatric illness that would prevent informed consent
  • Patients known to be infected with HIV or a history of AIDS are excluded.
  • Prior surgery for carcinoma of the cervix other than a biopsy.
  • Patients with para-aortic disease.
  • Previous pelvic radiation therapy or systemic chemotherapy is not permitted.
  • Women who are pregnant or breast-feeding are excluded from this study.
  • Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • Drugdocetaxel
  • ProcedureRadiation Therapy
06

Study locations

1 site
  • University of Rochester, Dept. Radiation Oncology
    Rochester, New York 14642, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00178269
Lead sponsor
University of Rochester
First posted
Sep 15, 2005
Start date
Jan 2005
Primary completion
Jun 2006
Last update
May 19, 2009

Study contacts

Yuhchyau Chen, MD, Ph.D
principal investigator · Universtiy of Rochester, Dept of Radiation Oncology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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