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Platinum-based Chemotherapy

Chemo-Radiation for Early-Stage Cervical Cancer

Phase 3
Waitlist Available
Led By Anuja Jhingran, MD
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
- Positive pelvic nodes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to date of death or last follow-up. analysis occurs after all patients have been potentially followed for 4 years.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial is studying how well giving chemotherapy and pelvic radiation therapy together with or without additional chemotherapy works in treating patients with high-risk early-stage cervical cancer.

Who is the study for?
This trial is for patients with high-risk early-stage cervical cancer who've had a radical hysterectomy. Eligible participants must have certain types of cervical cancer, no distant metastases, and their major organs functioning well. They should not have received prior chemotherapy or pelvic radiotherapy for the current cancer and must not have severe active co-morbidities.Check my eligibility
What is being tested?
The study is testing how effective chemotherapy (cisplatin, paclitaxel, carboplatin) combined with pelvic radiation therapy is compared to the same treatment plus additional chemotherapy in treating high-risk early-stage cervical cancer post-surgery.See study design
What are the potential side effects?
Chemotherapy drugs like cisplatin, paclitaxel, and carboplatin can cause side effects including nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, kidney problems and nerve damage which might lead to numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cervical cancer is confirmed and has high-risk features after surgery.
Select...
My cancer has spread to the lymph nodes in my pelvis.
Select...
My cancer has spread to the tissues next to my cervix.
Select...
My para-aortic nodes were removed and show no signs of cancer on a PET/CT scan.
Select...
I need a PET scan only if they found positive nodes during my surgery.
Select...
My cancer is in an early stage (IA2, IB, IIA) and hasn't spread far.
Select...
I had a major surgery to remove my uterus within the last 70 days.
Select...
My treatment plan includes testing of pelvic and para-aortic lymph nodes.
Select...
I haven't had a para-aortic lymph node dissection but had a negative common iliac node dissection.
Select...
My PET scan for para-aortic nodes was negative, and I didn't have a nodal dissection.
Select...
My cancer shows no large visible tumors after surgery.
Select...
My cancer does not have neuroendocrine features.
Select...
My cancer has not spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to date of death or last follow-up. analysis occurs after all patients have been potentially followed for 4 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to date of death or last follow-up. analysis occurs after all patients have been potentially followed for 4 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
Disease-free survival
Secondary outcome measures
Chemotherapy-induced neuropathy as measured by FACT-GOG/NTX4
Overall survival
Quality of life as measured by FACT-Cx and FACIT-D

Side effects data

From 2010 Phase 2 trial • 13 Patients • NCT02006667
46%
Platelet count decreased
38%
Nausea
23%
Chills
23%
Vomiting
23%
Fatigue
23%
White blood cell decreased
23%
Dyspnea
15%
Urinary tract infection
15%
Creatinine increased
15%
Anemia
15%
Weight loss
15%
Investigations-other
15%
Back pain
15%
Paresthesia
15%
Epistaxis
8%
Alkaline phosphatase increased
8%
Eyelid function disorder
8%
Nail infection
8%
Non-cardiac chest pain
8%
Sinus bradycardia
8%
Infections and infestations-others
8%
General disorders and administration site conditions-other
8%
Bronchial infection
8%
Diarrhea
8%
Bone pain
8%
Peripheral sensory neuropathy
8%
Fever
8%
Upper respiratory infection
8%
Confusion
8%
Tachyarrhythmia
8%
Gastrointestinal hermorrhage
8%
Ileus
8%
General disorders-other
8%
Catheter related infection
8%
Hematuria
8%
Urinary tract obstruction
8%
Pleural effusion
8%
Vertigo
8%
Endocrine disorders-other
8%
Neutrophil count decreased
8%
Arthralgia
8%
Pain in extremity
8%
Neck pain
8%
Generalized muscle weakness
8%
Neoplasms benign, malignant and unspecified-others
8%
Depression
8%
Alopecia
8%
Nail ridging
8%
Surgical and medical procedures-others
8%
Chill
8%
Gastrointestinal hemorrhage
8%
Arthritis
8%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab/Gemcitabine/Cisplatin

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
Group I: Arm II: Cisplatin/Radiation Therapy + Carboplatin/PaclitaxelExperimental Treatment3 Interventions
Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes 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 TherapyExperimental Treatment1 Intervention
Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
cisplatin
1997
Completed Phase 3
~3290
paclitaxel
1996
Completed Phase 3
~4310

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,689 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,562 Total Patients Enrolled
NRG OncologyOTHER
230 Previous Clinical Trials
100,416 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00980954 — Phase 3
Cervical Cancer Research Study Groups: Arm I: Cisplatin/Radiation Therapy, Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Cervical Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00980954 — Phase 3
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00980954 — Phase 3

Frequently Asked Questions

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

What cancers does cisplatin commonly target?

"cisplatin is most commonly used as treatment for advanced endometrial cancer. It can also be taken to treat other conditions like melanoma, neoplasm metastasis, lymphoma, and non-hodgkin."

Answered by AI

Can you please share other research that has been conducted with cisplatin?

"City of Hope Comprehensive Cancer Center first studied cisplatin in 1997 and there have been 2265 completed trials to date. There are 1592 clinical trials still underway, with a large contingent being based in Sacramento, Pennsylvania."

Answered by AI

Is this clinical trial available in multiple states?

"There are 6 sites enrolling patients for this trial, 3 of which are located in Wynnewood, Sacramento and Sioux Falls. The other 3 sites are in close proximity to these locations. If you enroll, it would be beneficial to choose the location closest to you in order to reduce travel."

Answered by AI

Has cisplatin been federally recognized in the United States?

"There is some clinical data supporting cisplatin's efficacy and it has undergone multiple rounds of testing for safety, so it received a score of 3."

Answered by AI

How many individuals are receiving care through this experiment?

"As of right now, this clinical trial is not open to new patients. It was originally posted on September 1st, 2009 and was most recently edited on April 4th, 2022. However, there are presently 408 trials actively recruiting patients with cervical cancer and 1592 studies using cisplatin that are still admitting patients."

Answered by AI

Are there still available positions for participants in this clinical trial?

"Unfortunately, this particular clinical trial is not presently looking for participants. Although, this may be subject to change as the study was most recently updated on 4/4/2022. There are 2000 other studies that are actively recruiting patients."

Answered by AI
~15 spots leftby Feb 2025