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Alkylating agents
Triapine + Chemotherapy/Radiation for Cervical and Vaginal Cancers
Phase 3
Waitlist Available
Led By Charles A Leath
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent
Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying radiation therapy and cisplatin with or without triapine in treating patients with newly diagnosed cervical or vaginal cancer.
Who is the study for?
This trial is for patients with advanced-stage cervical or vaginal cancer, specifically stages IB2, II, or IIIB-IVA. Participants must have adequate organ function (e.g., hemoglobin >10 g/dL, creatinine ≤1.5 mg/dL), no severe allergies to triapine, not be breastfeeding, and cannot have HIV or other conditions that would interfere with the study drugs.Check my eligibility
What is being tested?
The trial is testing if adding Triapine to standard chemotherapy (Cisplatin) and radiation therapy improves outcomes in treating advanced cervical and vaginal cancers. It's a phase III study where some patients will receive the usual treatment while others will get the new combination including Triapine.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues like fatigue, nausea, kidney problems from Cisplatin; plus potential risks from Triapine such as low blood counts and allergic reactions. Radiation may cause skin irritation and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I have a certain type of cervical or vaginal cancer that cannot be cured by surgery alone.
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My creatinine level is 1.5 mg/dL or lower.
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My kidney function is within the range to receive cisplatin.
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My blood sugar levels are under control.
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I do not have brain metastases.
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I do not have HIV or am not on HIV treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS) Rate at 3 Years
Secondary outcome measures
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Progression-free Survival (PFS) Rate at 3 Years
Other outcome measures
Intensity Modulated Radiation Therapy (IG-IMRT)
Metabolic Complete Response (mCR)
Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)Experimental Treatment6 Interventions
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (cisplatin, IMRT or RT, brachytherapy)Active Control6 Interventions
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Brachytherapy
2007
Completed Phase 3
~2100
Triapine
2006
Completed Phase 1
~30
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,680 Previous Clinical Trials
40,928,069 Total Patients Enrolled
NRG OncologyOTHER
232 Previous Clinical Trials
100,727 Total Patients Enrolled
Charles A LeathPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with G6PD deficiency.I do not have any major health issues that are not under control.I have another active cancer besides the one being treated.I can take care of myself but might not be able to do heavy physical work.I haven't had cancer, except for non-melanoma skin cancer or cervical carcinoma in situ, in the last 3 years.I have not had, nor am I planning to have, a hysterectomy as part of my cervical cancer treatment.My creatinine level is 1.5 mg/dL or lower.My kidney function is within the range to receive cisplatin.My blood sugar levels are under control.I am set to receive additional cancer treatment after my standard chemoradiation.I have a certain type of cervical or vaginal cancer that cannot be cured by surgery alone.I have vaginal cancer but didn't have a hysterectomy for cervical cancer in the last 5 years.I do not have a known G6PD deficiency.I do not have brain metastases.I do not have HIV or am not on HIV treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (cisplatin, IMRT or RT, brachytherapy)
- Group 2: Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
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 are the most common conditions that doctors use Radiation Therapy to improve?
"Patients with advanced ovarian cancer that has become unresponsive to conventional treatments as well as those with neoplasm metastasis can be helped by Radiation Therapy."
Answered by AI
How many people can potentially sign up for this clinical trial?
"Presently, this specific trial is not seeking more participants. Although, it is worth mentioning that the study was first posted on 1/15/2016 and was most recently updated on 10/18/2022. If you are interested in other studies, there are presently 3600 studies actively enrolling patients with malignant vaginal neoplasm and 774 trials for Radiation Therapy actively recruiting participants."
Answered by AI
Has Radiation Therapy been cleared by the FDA?
"Radiation Therapy received a score of 3 because there is some efficacy data along with multiple rounds of safety data."
Answered by AI
What comparable research has been done on other types of Radiation Therapy?
"774 clinical trials for Radiation Therapy are currently active with 300 of those studies in Phase 3. There is a global distribution of these trials with several hundred based in Shanghai, China."
Answered by AI
Are people presently being signed up for this experiment?
"This study is not currently enrolling patients. The clinical trial was originally posted on 1/15/2016 and was most recently updated on 10/18/2022. There are, however, 3600 other studies actively admitting patients with malignant vaginal neoplasm and 774 Radiation Therapy studies that are still enrolling patients."
Answered by AI
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