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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Cervical Cancer
Trial Information
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Locally Advanced Cervical Cancer
Status: No longer recruiting
Protocol Number: ML18418
Sponsor: F Hoffman-La Roche Ltd
Company Division: Pharmaceutical
Official Scientific Title: An open-label study of Xeloda plus radiotherapy on overall tumor response rate in treatment-naïve patients with locally advanced squamous cell cancer of the cervix
Brief Summary: This study will evaluate the efficacy and safety of oral Xeloda plus radiotherapy as a first-line treatment in patients with advanced squamous cell cervical cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
59
.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Single Group
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Cervical Cancer
Intervention Type: Drug
Intervention Name: capecitabine[Xeloda]
Primary Outcome: 1
.
Overall objective tumor response rate (compete response (CR) plus partial response (PR))
Key Secondary Outcomes: 1. Efficacy: 6 months of stable disease, time to progression, overall survival, duration of response. Safety: Adverse events (graded according to NCI CTCAE and RTOG), laboratory parameters, and ECOG PS
Inclusion Criteria:
- female patients 18-75 years of age;
- stage IIb-IIIb squamous cell cervical cancer;
- >=1 measurable lesion.
Exclusion Criteria:
- previous chemotherapy or radiotherapy;
- total hysterectomy;
- clinically significant cardiac disease;
- history of lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
- history of other malignancies, except cured basal cell cancer of the skin.
Gender: Females
Age Limits: Min: 18 Years Max: 75 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: July, 2005
Trial Registration Date: 10/27/2005
Date Last Updated: 09/16/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Chiang Mai 50202
Thailand
Phone: 888-662-6728 (U.S. Only)
View Google Map
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