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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
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
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
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 • NCT0200666746%
Platelet count decreased
38%
Nausea
23%
Fatigue
23%
Vomiting
23%
Chills
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%
Nail infection
8%
Bronchial infection
8%
Peripheral sensory neuropathy
8%
Bone pain
8%
Alkaline phosphatase increased
8%
Sinus bradycardia
8%
Non-cardiac chest pain
8%
Eyelid function disorder
8%
General disorders and administration site conditions-other
8%
Infections and infestations-others
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
64,689 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,915 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,614 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a severe lung condition that would stop me from joining the study.My cancer does not have neuroendocrine features.My cancer has not spread to distant parts of my body.I can carry out all my usual activities without help.I am HIV positive with a CD4 count of at least 350.I have had previous radiation treatment to my pelvis.I had a major surgery for my cancer that included removing my uterus and checking if the cancer has spread, within the last 70 days.My PET scans show no cancer in the para-aortic nodes.My cancer does not have large, visible tumors after surgery.I haven't had any other cancer besides the specified one in the last 3 years.I have not been hospitalized for heart issues in the last 6 months.I had a major heart attack in the last 6 months.I am receiving IV antibiotics for a bacterial or fungal infection.I have had chemotherapy for my current cervical cancer.My cervical cancer surgery showed high-risk features but no spread to para-aortic nodes.My cancer is in an early stage (IA2, IB, IIA).I have had lymph node sampling in my pelvis and near my aorta.I have a blood clotting disorder.I do not have any severe ongoing health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I: Cisplatin/Radiation Therapy
- Group 2: Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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