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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
Must not have
Patients with septicemia or severe infection
Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 11 years
Awards & highlights

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a severe infection or septicemia.
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My cancer has spread to areas near the uterus or I have positive surgical margins.
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I have a blockage in my intestines or bleeding in my digestive tract.
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I have cervix cancer and have had radiation or chemotherapy before.
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My kidney condition requires special adjustments for radiation therapy.
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I have a fistula following surgery.

Timeline

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
External Beam Radiation Therapy
2006
Completed Phase 3
~3150
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
71,045 Total Patients Enrolled
1 Trials studying Cervical Carcinoma
130 Patients Enrolled for Cervical Carcinoma
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,060 Total Patients Enrolled
20 Trials studying Cervical Carcinoma
29,779 Patients Enrolled for Cervical Carcinoma
GOG FoundationLead Sponsor
45 Previous Clinical Trials
17,093 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
~22 spots leftby Jul 2025
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