← Back to Search

Alkylating agents

External Beam Radiation Therapy for Cervical Cancer

Phase 3
Waitlist Available
Led By Kathleen N Moore
Research Sponsored by GOG Foundation
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 5 years from study randomization
Awards & highlights

Study Summary

This trial is testing whether giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works better than just giving cisplatin and radiation therapy in treating patients with cervical cancer.

Eligible Conditions
  • Cervical Cancer
  • Cervical Adenocarcinoma
  • Cervical Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from study randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from study randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival Rate at 5 Years
Secondary outcome measures
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year
Patterns of Disease Recurrence
Progression-free Survival Rate at 5 Years
+2 more

Side effects data

From 2021 Phase 3 trial • 926 Patients • NCT01414608
79%
Fatigue
76%
Nausea
73%
Diarrhea
71%
Lymphocyte count decreased
65%
Anemia
36%
Vomiting
35%
Abdominal pain
31%
Vaginal discharge
31%
Platelet count decreased
28%
Pelvic pain
26%
Neutrophil count decreased
24%
Peripheral sensory neuropathy
22%
General disorders NOS
20%
Cystitis noninfective
17%
Alanine aminotransferase increased
16%
Pain in extremity
14%
Dermatitis radiation
12%
Creatinine increased
12%
Dehydration
11%
Vaginal pain
10%
Myalgia
10%
Hemorrhage Bladder
9%
Aspartate aminotransferase increased
9%
Hearing impaired
8%
Proctitis
8%
Vaginal dryness
8%
Alopecia
7%
Hemorrhage Rectum
7%
Vaginal stricture
6%
Mucositis oral
6%
Thrombosis/Thrombus/Embolism
6%
Urinary tract pain
4%
Allergic reaction/ hypersensitivity
4%
Rectal pain
3%
Anal pain
3%
Colitis
3%
Lymphedema
2%
Perineal pain
2%
Telangiectasia
2%
Enterocolitis
2%
Febrile neutropenia
2%
Female genital tract fistula
2%
Peripheral motor neuropathy
2%
Tumour pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Chemoradiation
Standard Chemoradiation With Adjuvant Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (cisplatin, radiation therapy, brachytherapy, chemo)Experimental Treatment6 Interventions
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (cisplatin, radiation therapy, brachytherapy)Experimental Treatment4 Interventions
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Brachytherapy
2007
Completed Phase 3
~2100
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

GOG FoundationLead Sponsor
42 Previous Clinical Trials
15,815 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,924,955 Total Patients Enrolled
Kathleen N MoorePrincipal InvestigatorNRG Oncology

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
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
2012. "Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01414608.
~70 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top