NCT01717391 is a Phase 2 clinical trial of fluorothymidine F 18 in Uterine Cervical Neoplasms, sponsored by John M. Buatti.

Who is sponsoring NCT01717391?

NCT01717391 is sponsored by John M. Buatti.

What drugs are being tested in NCT01717391?

Interventions in NCT01717391: fluorothymidine F 18.

What condition does NCT01717391 study?

NCT01717391 studies Uterine Cervical Neoplasms, Endometrial Neoplasms, Anus Neoplasms, Rectal Neoplasms, Prostatic Neoplasms.

Is NCT01717391 still recruiting?

NCT01717391 is currently completed. Last updated 26 March 2019.

Are results published for NCT01717391?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-26 · How we verify

NCT01717391

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

Completed Phase 2 Results posted Last updated 26 March 2019

What this trial tests

Phase 2 trial testing fluorothymidine F 18 in Uterine Cervical Neoplasms in 36 participants. Completed in 30 April 2017.

Timeline

1 October 2012

Primary endpoint
29 February 2016

30 April 2017

Quick facts

Lead sponsor	John M. Buatti
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 October 2012
Primary completion	29 February 2016
Estimated completion	30 April 2017
Sites	1 location across United States

Drugs / interventions tested

fluorothymidine F 18 — full drug profile →

Conditions studied

Uterine Cervical Neoplasms — all drugs for Uterine Cervical Neoplasms →
Endometrial Neoplasms — all drugs for Endometrial Neoplasms →
Anus Neoplasms — all drugs for Anus Neoplasms →
Rectal Neoplasms — all drugs for Rectal Neoplasms →

Sponsor

John M. Buatti — full company profile →

Who can join

18 and older, any sex, with Uterine Cervical Neoplasms or Endometrial Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Difference From Baseline IMRT Plan (%) Primary · Baseline (pre-treatment)

The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor

% difference, volume receiving 5 Gray

Group	Value	95% CI
Basline FLT PET/CT (All Subjects)	-4.7	± 3.3

% difference, volume receiving 10 Gray

Group	Value	95% CI
Basline FLT PET/CT (All Subjects)	-9.3	± 4.2

% difference, volume receiving 20 Gray

Group	Value	95% CI
Basline FLT PET/CT (All Subjects)	-14.2	± 4.1

% difference, volume receiving 30 Gray

Group	Value	95% CI
Basline FLT PET/CT (All Subjects)	-13.4	± 7.6

% difference, dose to target (tumor) volume

Group	Value	95% CI
Basline FLT PET/CT (All Subjects)	-0.1	± 0.4

Chemotherapy Compliance Secondary · At 24 months

The number of participants who had chemotherapy withheld at least once for low blood counts.

Group	Value	95% CI
FLT PET/CT	7

Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts Secondary · baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment

White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up

Baseline (pre-treatment)

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	27
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 1

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	27
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 2

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	15
Bone-marrow Sparing Radiation Therapy (IMRT)	7
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	3

Therapy, week 3

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	13
Bone-marrow Sparing Radiation Therapy (IMRT)	5
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	1

Therapy, week 4

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	13
Bone-marrow Sparing Radiation Therapy (IMRT)	5
Bone-marrow Sparing Radiation Therapy (IMRT)	4
Bone-marrow Sparing Radiation Therapy (IMRT)	2

Therapy, week 5

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	10
Bone-marrow Sparing Radiation Therapy (IMRT)	3
Bone-marrow Sparing Radiation Therapy (IMRT)	3
Bone-marrow Sparing Radiation Therapy (IMRT)	1

30 days post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	20
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

1 year post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. Secondary · baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment

Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up

Baseline (pre-treatment)

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	27
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 1

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	27
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 2

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	9
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	2

Therapy, week 3

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	12
Bone-marrow Sparing Radiation Therapy (IMRT)	6
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	1

Therapy, week 4

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	15
Bone-marrow Sparing Radiation Therapy (IMRT)	6
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 5

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	9
Bone-marrow Sparing Radiation Therapy (IMRT)	7
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	0

30 days post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	17
Bone-marrow Sparing Radiation Therapy (IMRT)	4
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	0

1 year post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) Secondary · baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment

Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up

Baseline (pre-treatment)

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	27
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 1

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	25
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 2

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	8
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	1

Therapy, week 3

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	4
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	1

Therapy, week 4

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	17
Bone-marrow Sparing Radiation Therapy (IMRT)	5
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 5

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	13
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0

30 days post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	21
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

1 year post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. Secondary · baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment

Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up

Baseline (pre-treatment)

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	27
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 1

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	25
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 2

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	8
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	1

Therapy, week 3

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	4
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	1

Therapy, week 4

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	17
Bone-marrow Sparing Radiation Therapy (IMRT)	5
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Therapy, week 5

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	13
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0

30 days post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	21
Bone-marrow Sparing Radiation Therapy (IMRT)	1
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

1 year post-therapy

Group	Value	95% CI
Bone-marrow Sparing Radiation Therapy (IMRT)	16
Bone-marrow Sparing Radiation Therapy (IMRT)	2
Bone-marrow Sparing Radiation Therapy (IMRT)	0
Bone-marrow Sparing Radiation Therapy (IMRT)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for 48 hours after injection with FLT, the investigational drug under study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FLT PET/CT

Serious: 0/27 (0%)

Deaths: 0/27

Other adverse events (4 terms — click to expand)

Reaction	System	FLT PET/CT
Nausea, grade 1	Gastrointestinal disorders	—
Diarrhea, grade 1	Gastrointestinal disorders	—
Diarrhea, grade 2	Gastrointestinal disorders	—
Headache, grade 1	Nervous system disorders	—

Data from ClinicalTrials.gov NCT01717391 adverse events section.

Sponsor's own description

\[F-18\] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients.
McGuire SM, Bhatia SK, Sun W, Jacobson GM, et al · · 2016 · cited 36× · PMID 27319286 · DOI 10.1016/j.ijrobp.2016.04.009
Bone marrow sparing in intensity modulated proton therapy for cervical cancer: Efficacy and robustness under range and setup uncertainties.
Dinges E, Felderman N, McGuire S, Gross B, et al · · 2015 · cited 33× · PMID 25981130 · DOI 10.1016/j.radonc.2015.05.005

Verify or expand the search:

Other recruiting trials for Uterine Cervical Neoplasms

Currently open trials in the same condition.

NCT07305727 — A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer · recruiting
NCT07011836 — Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women · NA · recruiting
NCT06815939 — Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer · NA · recruiting
NCT06558682 — Neoadjuvant Therapy in Cervical Cancer · NA · recruiting
NCT06509724 — Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy · Phase 3 · recruiting

Other John M. Buatti trials

Trials by the same sponsor.

NCT07447531 — T2 Star Magnetic Resonance Imaging and Biomarker Blood Testing to Predict the Change and Progress of Malignant Gliomas · NA · recruiting
NCT03506139 — Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma · Phase 2 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01717391 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by John M. Buatti
Last refreshed: 26 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01717391.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01717391

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Uterine Cervical Neoplasms

Other John M. Buatti trials

Verify against primary sources