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Alkylating agents

Phase II for Cervical Cancer

Phase 2 & 3
Waitlist Available
Led By Loren Mell, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months post treatment
Awards & highlights

Study Summary

The purpose of this study is to find out whether patients with cervical cancer treated with IMRT have less side effects with equal cancer control compared to standard radiation techniques. With standard radiation techniques, normal pelvic organs near the tumor receive radiation dose, which leads to side effects. IMRT is a new radiation technique that can reduce radiation dose to these organs and may reduce side effects. Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute hematologic and gastrointestinal toxicity for cervical cancer patients treated with concurrent cisplatin.

Eligible Conditions
  • Cervical Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Number of Patients with Acute and Late Adverse Events as a Measure of Safety and Tolerability
Number of Patients with Locoregional Failure as a Measure of Recurrence

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase III - BExperimental Treatment2 Interventions
Patients in Phase III, Arm B receive IMRT with concurrent cisplatin 40 mg/m2
Group II: Phase IIExperimental Treatment2 Interventions
All patients receive IMRT with concurrent cisplatin 40 mg/m2
Group III: Phase III - AActive Control1 Intervention
Patients in Phase III, Arm A receive 4-field box RT with concurrent cisplatin 40 mg/m2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~60
Cisplatin
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,337 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,417 Total Patients Enrolled
Loren Mell, MDPrincipal InvestigatorUniversity of California, San Diego
3 Previous Clinical Trials
149 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Loren Mell, MD 2011. "Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01554397.
All > Cervical Cancer
~5 spots leftby Apr 2025
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