NCT02879214|UnknownPhase 2DMC
Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer
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Sponsor study identifier
interventional
50
1 country
1
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 10, 2016
Actual (reported)August 25, 2016
Actual (reported)December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To observe the efficacy from radiation therapy dose escalation
40 participants will be evaluated with treatment-related adverse events as assessed by CTCAE v4.0
4 year
To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix
4 years
Disease free survival(DFS)
4 years
To Maximal downstage locally advanced squamous cell cervical cancer before minimal invasive surgical resection. The SIDE study is to use both RT dose escalation to the biological target defined by PET and Chemo dose escalation composited with two drugs to achieve maximal reduction of tumor burden, providing feasibility of minimal invasive surgical resection.
Prior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sichuan PPH, Departmentn of Gynecology Oncology
Chengdu, Sichuan, 610072, China
Ming Zeng, MD PhD
Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
First Submitted
August 10, 2016
First Posted
August 25, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 18, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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