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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Philippines
Thailand
