Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage IB-IVA Cervical Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01295502|
Recruitment Status : Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage IB Cervical Cancer AJCC v6 and v7 Stage IIA Cervical Cancer AJCC v7 Stage IIB Cervical Cancer AJCC v6 and v7 Stage IIIA Cervical Cancer AJCC v6 and v7 Stage IIIB Cervical Cancer AJCC v6 and v7 Stage IVA Cervical Cancer AJCC v6 and v7||Drug: Carboplatin Drug: Cisplatin Radiation: External Beam Radiation Therapy Radiation: Internal Radiation Therapy Drug: Paclitaxel||Phase 1|
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of adjuvant carboplatin and paclitaxel chemotherapy following concurrent weekly cisplatin chemotherapy and extended field radiation in women with newly diagnosed stage IB-IVA cervical cancer, with positive para-aortic nodes.
II. To determine the feasibility of the treatment regimen over the four cycles of adjuvant chemotherapy once the MTD is estimated.
III. To assess the toxicities of the treatment regimen the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
I. To assess the response rate to this treatment regimen in patients with measurable disease.
II. To examine progression-free survival for one year on this treatment regimen.
III. To examine overall survival. IV. To examine the location of recurrence, loco-regional versus distant for one year after completion of therapy.
V. To estimate the frequency of chronic toxicities experienced within one year of study entry.
OUTLINE: This is a dose-escalation study of carboplatin and paclitaxel.
Patients receive cisplatin intravenously (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.
After completion of study therapy, patients are followed up every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes|
|Actual Study Start Date :||April 4, 2011|
|Estimated Primary Completion Date :||December 2, 2019|
Experimental: Treatment (radiation, cisplatin, paclitaxel, carboplatin)
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.
Radiation: External Beam Radiation Therapy
Radiation: Internal Radiation Therapy
- MTD of adjuvant carboplatin and paclitaxel determined based on the dose-limiting toxicities assessed by NCI CTCAE version 4 [ Time Frame: 21 days ]
- Objective tumor response rate in patients enrolled with measurable disease [ Time Frame: Up to 1 year ]Will be tabulated overall.
- Progression-free survival (PFS) [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed at 1 year ]PFS will be summarized using Kaplan-Meier plots.
- Overall survival [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 1 year ]Survival will be summarized using Kaplan-Meier plots.
- 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 [ Time Frame: Up to 1 year ]
- Chronic toxicities experienced classified using the CTCAE version 4 [ Time Frame: Within 1 year of study entry ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295502
|United States, California|
|UC Irvine Health/Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|The Hospital of Central Connecticut|
|New Britain, Connecticut, United States, 06050|
|United States, Georgia|
|Augusta University Medical Center|
|Augusta, Georgia, United States, 30912|
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Ohio|
|Summa Akron City Hospital/Cooper Cancer Center|
|Akron, Ohio, United States, 44304|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Riverside Methodist Hospital|
|Columbus, Ohio, United States, 43214|
|Hillcrest Hospital Cancer Center|
|Mayfield Heights, Ohio, United States, 44124|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Cecelia H Boardman||NRG Oncology|