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Alkylating agents
Chemoradiation + Chemotherapy for Cervical Cancer
Phase 1
Waitlist Available
Led By Cecelia H Boardman
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine =< institutional upper limit normal (ULN); Note: if creatinine > ULN, creatinine clearance must be > 50 mL/min
Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing paclitaxel and carboplatin as a follow-up to cisplatin and radiation therapy for cervical cancer patients to see if it is more effective in killing tumor cells.
Who is the study for?
This trial is for patients with confirmed cervical cancer stages IB-IVA who have positive para-aortic lymph nodes. They must be in good physical condition, not pregnant, and able to follow the study's procedures. Excluded are those with active infections, recent major surgery, significant heart disease, previous treatments for this cancer or other invasive malignancies within five years.Check my eligibility
What is being tested?
The trial tests how well paclitaxel and carboplatin work after initial treatment with cisplatin and radiation therapy in cervical cancer patients. It aims to find the best dose of chemotherapy following radiation to kill more tumor cells.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, nerve damage (neuropathy), blood cell count changes increasing infection risk; kidney function may also be affected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
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I have had a stent or tube placed for my blocked ureter before joining the study.
Select...
I can take care of myself but might not be able to do heavy physical work.
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My nerve damage symptoms are mild or not present.
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My cervical cancer is confirmed and has spread to the lymph nodes near my aorta.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD of adjuvant carboplatin and paclitaxel determined based on the dose-limiting toxicities assessed by NCI CTCAE version 4
Secondary outcome measures
Chronic toxicities experienced classified using the CTCAE version 4
Location of recurrence (loco-regional versus distant) defined as newly evident disease for patients who have no evidence of disease at baseline or progressive disease for patients who have strictly non-measurable disease at baseline
Objective tumor response rate in patients enrolled with measurable disease
+2 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation, cisplatin, paclitaxel, carboplatin)Experimental Treatment5 Interventions
Patients receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and undergo extended-field radiotherapy daily 5 days a week for 6 weeks followed by brachytherapy. Beginning 4-6 weeks after completion of chemoradiation, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Internal Radiation Therapy
2006
Completed Phase 3
~290
Paclitaxel
FDA approved
Carboplatin
FDA approved
Platinum
Not yet FDA approved
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,881 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,108 Total Patients Enrolled
Cecelia H BoardmanPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any cancer other than non-melanoma skin cancer in the last 5 years.I have had radiation, chemotherapy, or any treatment for my cancer before.I have a unique kidney condition that affects how radiation therapy is given.I haven't had serious heart problems in the last 6 months.My kidney function, measured by creatinine levels, is within the normal range.I have had a stent or tube placed for my blocked ureter before joining the study.My cervical cancer is confirmed and has spread to the lymph nodes near my aorta.I will have a hearing test before starting treatment and often if I already have or develop hearing loss.I currently have an active infection.I can take care of myself but might not be able to do heavy physical work.I have not had major surgery, except for a biopsy, in the last 30 days.My nerve damage symptoms are mild or not present.You have had allergic reactions to products that contain Cremophor EL.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation, cisplatin, paclitaxel, carboplatin)
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
In how many sites can this trial be accessed?
"In total, 14 clinical sites are participating in this study. Examples include the University of Iowa/Holden Comprehensive Cancer Center (Iowa City), Cleveland Clinic Foundation (Cleveland) and University of Oklahoma Health Sciences Centre (Oklahoma City)."
Answered by AI
Are there vacancies available in this clinical trial for volunteers?
"The recruitment for this particular study has been suspended since 3/8/2019. If you are looking to join other trials, 2866 medical studies related to adenocarcinoma and 1,571 examinations involving Cisplatin have open enrollments at present."
Answered by AI
Have there been any other research endeavors involving Cisplatin?
"Cisplatin was first investigated at City of Hope Comprehensive Cancer Center in 1997 and has since amassed 2330 completed clinical trials. In the present day, 1571 active studies are being conducted with numerous sites located in Iowa City, Iowa."
Answered by AI
What illnesses does Cisplatin typically target?
"Generally, cisplatin is assigned to address advanced cases of endometrial cancer. However, it may also be used as a remedy for melanoma, neoplasm metastasis, lymphoma and non-Hodgkin's disease."
Answered by AI
What side effects have been observed from Cisplatin treatment?
"Due to the limited research done on Cisplatin, we have assigned it a safety score of 1. This is in line with Phase 1 trial standards as there has been little evidence indicating its efficacy or safety."
Answered by AI
How many individuals are currently participating in the research study?
"This investigation is no longer accepting new applicants, having been first posted on April 4th 2011 and last updated March 8th 2019. If you are searching for alternative trials to join, there currently exist 2866 adenocarcinoma studies recruiting patients and 1571 Cisplatin experiments that require volunteers."
Answered by AI
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