← Back to Search

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Select...

My cervical cancer was initially treated with surgery to remove the uterus and pelvic lymph nodes.

Select...

My tumor is at least 5 cm and not deeply embedded.

Select...

My tumor is at least 4 cm and has grown deep into the tissue.

Select...

My kidney function is normal or nearly normal.

Select...

I can take care of myself but may not be able to do heavy physical work.

Select...

My tumor is at least 2 cm and located in the middle third of the affected area.

Select...

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:

Select...

I have a severe infection or septicemia.

Select...

My cancer has spread to areas near the uterus or I have positive surgical margins.

Select...

I have a blockage in my intestines or bleeding in my digestive tract.

Select...

I have cervix cancer and have had radiation or chemotherapy before.

Select...

My kidney condition requires special adjustments for radiation therapy.

Select...

I have a fistula following surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 11 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence-free survival (RFS)

Secondary study objectives

Incidence of adverse events

Local control

Overall survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3120

External Beam Radiation Therapy

2006