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Platinum-based Chemotherapy

Radiation Therapy + Chemotherapy for Cervical Cancer

Phase 3
Waitlist Available
Led By Sang Y Ryu
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
Superficial third penetration, clinical tumor >= 5 cm
Screening 3 weeks
Treatment Varies
Follow Up up to 11 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with stage I-IIA cervical cancer who had surgery. Eligible participants must have certain types of cervical cancer, adequate organ function, and no severe infections or other cancers in the last five years. They should be able to complete the study and follow-up.Check my eligibility
What is being tested?
The trial is testing if adding chemotherapy (Cisplatin) to radiation therapy improves outcomes compared to radiation alone after surgery in treating early-stage cervical cancer. It's a phase III study where patients are randomly assigned to one of the treatments.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, kidney issues from Cisplatin; skin irritation, bowel/bladder problems from radiation; plus risks associated with anesthesia and surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cervical cancer was initially treated with surgery to remove the uterus and pelvic lymph nodes.
My tumor is at least 5 cm and not deeply embedded.
My tumor is at least 4 cm and has grown deep into the tissue.
My kidney function is normal or nearly normal.
I can take care of myself but may not be able to do heavy physical work.
My tumor is at least 2 cm and located in the middle third of the affected area.
I had surgery between 3 to 8 weeks ago.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 11 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 11 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence-free survival (RFS)
Secondary outcome measures
Incidence of adverse events
Local control
Overall survival (OS)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (cisplatin, EBRT, IMRT)Experimental Treatment6 Interventions
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (EBRT, IMRT)Active Control5 Interventions
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
External Beam Radiation Therapy
Completed Phase 3
Intensity-Modulated Radiation Therapy
Completed Phase 3

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,585 Total Patients Enrolled
1 Trials studying Cervical Carcinoma
130 Patients Enrolled for Cervical Carcinoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,812 Total Patients Enrolled
20 Trials studying Cervical Carcinoma
29,779 Patients Enrolled for Cervical Carcinoma
GOG FoundationLead Sponsor
41 Previous Clinical Trials
15,800 Total Patients Enrolled

Media Library

Cisplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01101451 — Phase 3
Cervical Carcinoma Research Study Groups: Arm I (EBRT, IMRT), Arm II (cisplatin, EBRT, IMRT)
Cervical Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01101451 — Phase 3
Cisplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01101451 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~23 spots leftby Apr 2025