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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 below
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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.
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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 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
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%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
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
Paclitaxel
FDA approved
Internal Radiation Therapy
2006
Completed Phase 3
~290
Carboplatin
FDA approved
Platinum
Not yet FDA approved
External Beam Radiation Therapy
2006
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
71,341 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,734 Previous Clinical Trials
40,967,559 Total Patients Enrolled
Cecelia H BoardmanPrincipal InvestigatorNRG Oncology

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01295502 — Phase 1
Cervical Adenocarcinoma Research Study Groups: Treatment (radiation, cisplatin, paclitaxel, carboplatin)
Cervical Adenocarcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01295502 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01295502 — Phase 1
~3 spots leftby Jun 2025
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