Trial · NCT00068419

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

NCT00068419, Phase 2, Completed, Children's Oncology Group; results first posted 2013-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor. Trials, record NCT00068419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00068419

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Trial

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

Title: Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
NCT number: NCT00068419
Status: Completed
Phases: Phase 2
Enrollment: 70 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Desmoid Tumor
Interventions: tamoxifen citrate, sulindac, laboratory biomarker analysis
First posted: 2003-09-11
Last updated: 2020-02-19
Results first posted: 2013-12-04

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Percentage of Patients Failure Free at 2 Years Following Study Entry	Up to 2 years	Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Primary	Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.	Up to 12 months	The percentage of patients experiencing a grade 3 or higher adverse event as assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0
Secondary	Percentage of Patients With Tumor Response From Imaging	Baseline up to 5 years	Percentage of patients with a tumor response where tumor response is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary	Mean Change in Response Measured by MRI	From baseline to up to 5 years	The mean change in response measured by MRI. Response is assessed by the lesion size which is derived from the sum of the longest of the three orthogonal diameters (from MRI) of each target lesion.
Secondary	Percentage of Patients Failure Free at 2 Years by Pathological Response	From enrollment to up to 2 years	The failure free survival is compared by the log-rank test between patient subgroups defined by pathological response of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression
Secondary	Percentage of Patients Experiencing Short-term Endocrine Toxicity	At study entry	The percentage of patients experiencing short-term endocrine toxicity between treatment groups is compared using the chi-square test

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Patients Failure Free at 2 Years Following Study Entry	Up to 2 years	All eligible patients.	percentage of participants	NUMBER
PRIMARY	Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.	Up to 12 months	All eligible patients	Percentage of participants	NUMBER
SECONDARY	Percentage of Patients With Tumor Response From Imaging	Baseline up to 5 years	All eligible patients	Percentage of participants	NUMBER
SECONDARY	Mean Change in Response Measured by MRI	From baseline to up to 5 years	Outcome not reported because the required data were not recorded.
SECONDARY	Percentage of Patients Failure Free at 2 Years by Pathological Response	From enrollment to up to 2 years	Data not available for analysis due to no data were collected
SECONDARY	Percentage of Patients Experiencing Short-term Endocrine Toxicity	At study entry	Data not available for analysis due to no data were collected.

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Percentage of Patients Failure Free at 2 Years Following Study Entry	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	36	95% Confidence Interval 23 to 48	percentage of participants
Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	3.4	95% Confidence Interval 0 to 8.0	Percentage of participants
Percentage of Patients With Tumor Response From Imaging	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	8.0	95% Confidence Interval 1.1 to 14.9	Percentage of participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	70
Overall Study	COMPLETED	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	10
Overall Study	NOT COMPLETED	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	60

Source ClinicalTrials.gov

Adverse events90

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
other	Abdominal pain	Gastrointestinal disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	20	59
other	Acidosis	Metabolism and nutrition disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	2	59
other	Alanine aminotransferase increased	Investigations	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	8	59
other	Alkaline phosphatase increased	Investigations	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	2	59
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	1	59
other	Anemia	Blood and lymphatic system disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	6	59
other	Anorexia	Metabolism and nutrition disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	2	59
other	Arthralgia	Musculoskeletal and connective tissue disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	2	59
other	Aspartate aminotransferase increased	Investigations	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	7	59
other	Ataxia	Nervous system disorders	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	1	59

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)
Total, other adverse events	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	42	59
Total, serious adverse events	Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)	2	59

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
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT00068419

GET https://conductscience.org/api/trials/v1/NCT00068419/events?page=2

API reference For AI assistants