Cisplatin for Cervical Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Medical Center New Orleans, New Orleans, LACervical Carcinoma+6 MoreCisplatin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial compares radiation therapy with chemotherapy to radiation therapy alone to see which is more effective in treating patients with early cervical cancer who have already undergone surgery.

Eligible Conditions
  • Cervical Squamous Cell Carcinoma
  • Stage IA Cervical Cancer
  • Stage IB Cervical Cancer
  • Cervical Adenosquamous Carcinoma
  • Cervical Adenocarcinoma
  • Stage I Cervical Cancer
  • Stage IIA Cervical Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 11 years

Year 11
Overall survival (OS)
Year 11
Recurrence-free survival (RFS)
Up to 11 years
Local control
Patient risk-benefit
Site(s) of recurrence
Treatment compliance
Up to 5 years
Incidence of adverse events
Month 9
Quality of life

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm I (EBRT, IMRT)
1 of 2
Arm II (cisplatin, EBRT, IMRT)
1 of 2

Active Control

Experimental Treatment

341 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 3

Arm II (cisplatin, EBRT, IMRT)Experimental Group · 6 Interventions: Questionnaire Administration, Laboratory Biomarker Analysis, Cisplatin, External Beam Radiation Therapy, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment · Intervention Types: Other, Other, Drug, Radiation, Radiation, Other
Arm I (EBRT, IMRT)ActiveComparator Group · 5 Interventions: Questionnaire Administration, Laboratory Biomarker Analysis, External Beam Radiation Therapy, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment · Intervention Types: Other, Other, Radiation, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
External Beam Radiation Therapy
2006
Completed Phase 3
~3050
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1680

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 11 years

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
249 Previous Clinical Trials
68,998 Total Patients Enrolled
1 Trials studying Cervical Carcinoma
130 Patients Enrolled for Cervical Carcinoma
GOG FoundationLead Sponsor
30 Previous Clinical Trials
12,003 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,156 Previous Clinical Trials
41,163,265 Total Patients Enrolled
19 Trials studying Cervical Carcinoma
29,739 Patients Enrolled for Cervical Carcinoma
Sang Y RyuPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

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Frequently Asked Questions

Are there other ongoing investigations utilizing Cisplatin?

"The year 1997 saw City of Hope Comprehensive Cancer Center first study cisplatin. In the years since, there have been a total of 1686 completed studies with 773 ongoing trials. Many of these are located in Columbus, Ohio." - Anonymous Online Contributor

Unverified Answer

Are Canadian medical facilities part of this research project?

"There are 100 hospitals and other medical facilities participating in this trial, including Comprehensive Cancer Centers of Nevada in Columbus, OptumCare Cancer Care at Fort Apache in Portsmouth, Riverside Methodist Hospital in Toledo." - Anonymous Online Contributor

Unverified Answer

What diseases or conditions is Cisplatin used to treat?

"While most commonly used to treat neoplasm metastasis, Cisplatin can also be administered to patients with advanced ovarian cancer that has not responded well to other treatments." - Anonymous Online Contributor

Unverified Answer

Are there any severe side effects that have been associated with Cisplatin?

"Cisplatin has received a safety score of 3. This is based on the fact that it is Phase 3 trial, meaning there have been multiple rounds of data supporting its efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.