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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

Timeline

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

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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.

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

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

~3070

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

0 / 7Eligibility criteria met

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

Recent research and studies

Journal of Gynecologic OncologyJournal

Chemoradiotherapy Is Not Superior to Radiotherapy Alone After Radical Surgery for Cervical Cancer Patients with Intermediate-risk Factor

Kim, Hakyoung, Won Park, Young Seok Kim, and Yeon Joo Kim. 2020. “Chemoradiotherapy Is Not Superior to Radiotherapy Alone After Radical Surgery for Cervical Cancer Patients with Intermediate-risk Factor”. Journal of Gynecologic Oncology. Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology and Colposcopy. doi:10.3802/jgo.2020.31.e35.

clinicaltrials.govStudy

Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery

2010. "Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01101451.

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