Trial · NCT01554397

Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

NCT01554397, Phase 2, Phase 3, Completed, University of California, San Diego; results first posted 2024-11-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer. Trials, record NCT01554397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01554397

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
NCT number: NCT01554397
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 101 participants, actual
Lead sponsor: University of California, San Diego
Conditions: Cervical Cancer
Interventions: PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Cisplatin, IMRT
First posted: 2012-03-15
Last updated: 2024-11-29
Results first posted: 2024-11-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Event (Acute Hematologic or GI Toxicity)	Up to 30 days post radiation, about one month	Acute grade \>= 3 neutropenia or clinically significant \>=2 diarrhea or any grade \>=3 GI toxicity
Secondary	Progression-free Survival	Up to 36 Months post treatment, a total of about 38 months	Time from registration to first recurrence of disease or death from any cause
Secondary	Acute Adverse Events	Up to 30 days post-treatment, about one month	Acute grade 2 and 3 Adverse Events occurring Up to 30 days post-treatment

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Primary Event (Acute Hematologic or GI Toxicity)	Up to 30 days post radiation, about one month	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival	Up to 36 Months post treatment, a total of about 38 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Acute Adverse Events	Up to 30 days post-treatment, about one month	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Primary Event (Acute Hematologic or GI Toxicity)	IMRT Arm (Phase II)		55	Participants
Primary Event (Acute Hematologic or GI Toxicity)	PET-Guided BMS-IMRT (Phase II)		46	Participants
Progression-free Survival	PET-Guided Bone Marrow-Sparing IMRT		46	Participants
Progression-free Survival	IMRT		55	Participants
Acute Adverse Events	PET-Guided Bone Marrow-Sparing IMRT	Grade 2 or higher GI toxicity	17	participants
Acute Adverse Events	IMRT	Grade 2 or higher GI toxicity	17	participants
Acute Adverse Events	PET-Guided Bone Marrow-Sparing IMRT	Grade 3 or higher GI toxicity	2	participants
Acute Adverse Events	IMRT	Grade 3 or higher GI toxicity	1	participants
Acute Adverse Events	PET-Guided Bone Marrow-Sparing IMRT	Grade 3 or higher hematologic toxicity	17	participants
Acute Adverse Events	IMRT	Grade 3 or higher hematologic toxicity	25	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IMRT	63
Overall Study	STARTED	PET-Guided Bone Marrow-Sparing IMRT	46
Overall Study	COMPLETED	IMRT	55
Overall Study	COMPLETED	PET-Guided Bone Marrow-Sparing IMRT	46
Overall Study	NOT COMPLETED	IMRT	8
Overall Study	NOT COMPLETED	PET-Guided Bone Marrow-Sparing IMRT	0

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Clinically significant GI toxicity	Gastrointestinal disorders	IMRT	18	55	18
other	Clinically significant GI toxicity	Gastrointestinal disorders	PET-Guided Bone Marrow-Sparing IMRT	19	46	19
other	Grade 3 or higher neutropenia	Investigations	IMRT	50	55	50
other	Grade 3 or higher neutropenia	Investigations	PET-Guided Bone Marrow-Sparing IMRT	28	46	28
other	Grade 2 GI toxicity	Gastrointestinal disorders	IMRT	17	55	17
other	Grade 2 GI toxicity	Gastrointestinal disorders	PET-Guided Bone Marrow-Sparing IMRT	17	46	17
other	Grade 3 or higher GI toxicity	Gastrointestinal disorders	IMRT	1	55	1
other	Grade 3 or higher GI toxicity	Gastrointestinal disorders	PET-Guided Bone Marrow-Sparing IMRT	2	46	2
other	Grade 3 or higher hematologic toxicity	Investigations	IMRT	25	55	25
other	Grade 3 or higher hematologic toxicity	Investigations	PET-Guided Bone Marrow-Sparing IMRT	17	46	17

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IMRT	0	55
Total, all-cause mortality	PET-Guided Bone Marrow-Sparing IMRT	0	46
Total, other adverse events	IMRT	55	55
Total, other adverse events	PET-Guided Bone Marrow-Sparing IMRT	46	46
Total, serious adverse events	IMRT	0	55
Total, serious adverse events	PET-Guided Bone Marrow-Sparing IMRT	0	46

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21CA162718	Image-guided bone marrow-sparing IMRT for cervical cancer	MELL, LOREN K.	UNIVERSITY OF CALIFORNIA, SAN DIEGO	NATIONAL CANCER INSTITUTE	2011 to 2012

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
PET-Guided Bone Marrow-Sparing IMRT vs IMRT: Progression-free Survival	Trial comparisons
IMRT vs PET-Guided Bone Marrow-Sparing IMRT: deaths from any cause	Trial comparisons
IMRT Arm (Phase II) vs PET-Guided BMS-IMRT (Phase II): Primary Event (Acute Hematologic or GI Toxicity)	Trial comparisons
IMRT vs PET-Guided Bone Marrow-Sparing IMRT: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01554397

GET https://conductscience.org/api/trials/v1/NCT01554397/registered

API reference For AI assistants