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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
No neuroendocrine histology
No distant metastases
Must not have
Chronic obstructive pulmonary disease exacerbation or other respiratory illness precluding study therapy at study entry
Overlap of radiotherapy fields due to prior radiotherapy to the pelvis
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

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
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My cancer does not have neuroendocrine features.
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My cancer has not spread to distant parts of my body.
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I can carry out all my usual activities without help.
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My PET scans show no cancer in the para-aortic nodes.
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My cancer does not have large, visible tumors after surgery.
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My cervical cancer surgery showed high-risk features but no spread to para-aortic nodes.
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My cancer is in an early stage (IA2, IB, IIA).
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I have had lymph node sampling in my pelvis and near my aorta.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a severe lung condition that would stop me from joining the study.
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I have had previous radiation treatment to my pelvis.
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I have not been hospitalized for heart issues in the last 6 months.
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I am receiving IV antibiotics for a bacterial or fungal infection.
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I have had chemotherapy for my current cervical cancer.
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I have a blood clotting disorder.

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%
Fatigue
23%
White blood cell decreased
23%
Vomiting
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%
Sinus bradycardia
8%
Non-cardiac chest pain
8%
Bronchial infection
8%
Eyelid function disorder
8%
Bone pain
8%
Infections and infestations-others
8%
Nail infection
8%
General disorders and administration site conditions-other
8%
Peripheral sensory neuropathy
8%
Alkaline phosphatase increased
8%
Diarrhea
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

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
64,688 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,163 Total Patients Enrolled
NRG OncologyOTHER
232 Previous Clinical Trials
100,511 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
~15 spots leftby Jul 2025
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