CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Cisplatin 40 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01554397
NCT01554397Phase 3Completed
CompareCT.gov

Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

University of California, San Diego·interventional·Posted Mar 15, 2012·Updated Nov 29, 2024

In Brief

A Phase 3 clinical trial evaluating PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Cisplatin, and 1 other intervention for Cervical Cancer. Completed, enrolled 101 participants across 7 sites in 6 countries.

Detailed Summary

The purpose of this study is to find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). The hypothesis is that PET-guided Bone Marrow Sparing IMRT will reduce acute hematologic and gastrointestinal toxicity and increase chemotherapy tolerance for cervical cancer patients treated with concurrent cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesChina, Czechia, India, Poland, Thailand, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2012
Enrollment StartOct 13, 2011
Primary CompletionJun 1, 2021
Study CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 14.3 years ago

Interventions

PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)radiation

IMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks with PET-guided Bone Marrow-Sparing

Cisplatindrug

Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks

IMRTradiation

IMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks