Trial · NCT02017704

Chemoradiation or Brachytherapy for Rectal Cancer

NCT02017704, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2023-02-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Chemoradiation or Brachytherapy for Rectal Cancer. Trials, record NCT02017704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02017704

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Trial

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

Title: Chemoradiation or Brachytherapy for Rectal Cancer
NCT number: NCT02017704
Status: Completed
Phases: Phase 2
Enrollment: 9 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Rectal Cancer
Interventions: Endo-HDR (if randomized to this arm), capecitabine and IMRT (if randomized to this arm), IMRT (intensity modulated radiation therapy), FOLFOX6, Surgery
First posted: 2013-12-23
Last updated: 2023-10-17
Results first posted: 2023-02-24

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Number of Patients With Pathologic Complete Response	Up to 60 months	Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after the treatment for each arm. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines: * Complete response - no remaining viable cancer cells * Moderate response - only small clusters/single cancer cells remain * Minimal response - residual cancer remaining, but with predominant fibrosis * Poor response - minimal/no tumor kills, extensive residual cancer
Secondary	Number of Participants With Grade 3 or Higher Adverse Events	Up to 60 months	Number of participants with grade 3 or higher adverse events will be listed by relationship. Grading is by CTCAE 4 guidelines. Relationship, as determined by PI, is unrelated/unlikely/possible/probable/definite.
Secondary	Change in EORTC QLQ-C30 Global Health Status Score	baseline, preop, postop, and at follow ups Y1-5	Patients were given the EORTC QLQ-C30 at baseline, preop, postop, and at follow ups Y1-5. The forms were scored as per the manual available at EORTC. Raw scores are transformed to fall in a range of 0-100. Generally, higher scores on QoL scales represent higher levels of QoL. The scores are reported as the mean of the Global Health Status/QoL scale score when more than 1 patient completed the form for a time point. If only 1 form was available for a time point, then the score for that form is reported.
Secondary	Time to Death	Up to 60 months	Assessing the difference time to death rates among study participants.
Secondary	Time to Distant Metastases Free Survival	Up to 60 months	Compare distant metastasis for both Endo-HDR and CRT.
Secondary	Time to Progression Free Survival	Up to 60 months	Compare progression free survival for both Endo-HDR and CRT.
Secondary	Time to Local Disease Recurrence	Up to 60 months	Compare locoregional control for both Endo-HDR and CRT.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Pathologic Complete Response	Up to 60 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Grade 3 or Higher Adverse Events	Up to 60 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in EORTC QLQ-C30 Global Health Status Score	baseline, preop, postop, and at follow ups Y1-5	3 patients randomised to IMRT arm had at least 1 form completed. 5 patients randomised to the ENDO arm had at least 1 form completed.	score on a scale	MEAN
SECONDARY	Time to Death	Up to 60 months	No patients were deceased during the study period.
SECONDARY	Time to Distant Metastases Free Survival	Up to 60 months	No patients had metastases during study period.
SECONDARY	Time to Progression Free Survival	Up to 60 months	No patients had progression during study period.
SECONDARY	Time to Local Disease Recurrence	Up to 60 months	No patients had locoregional recurrence during study period.

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Spread	Units
Number of Patients With Pathologic Complete Response	IMRT and Capecitabine		0		Participants
Number of Patients With Pathologic Complete Response	Endo-HDR		2		Participants
Number of Participants With Grade 3 or Higher Adverse Events	IMRT and Capecitabine	Grade: 3; Relationship: probable	1		Participants
Number of Participants With Grade 3 or Higher Adverse Events	Endo-HDR	Grade: 3; Relationship: probable	1		Participants
Number of Participants With Grade 3 or Higher Adverse Events	IMRT and Capecitabine	Grade: 3; Relationship: possible	1		Participants
Number of Participants With Grade 3 or Higher Adverse Events	Endo-HDR	Grade: 3; Relationship: possible	1		Participants
Number of Participants With Grade 3 or Higher Adverse Events	IMRT and Capecitabine	Grade 3; Relationship: Unlikely	1		Participants
Number of Participants With Grade 3 or Higher Adverse Events	Endo-HDR	Grade 3; Relationship: Unlikely	0		Participants
Change in EORTC QLQ-C30 Global Health Status Score	IMRT and Capecitabine	baseline	83	Full Range 83 to 83	score on a scale
Change in EORTC QLQ-C30 Global Health Status Score	Endo-HDR	baseline	71.2	Full Range 41 to 83	score on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	IMRT and Capecitabine	4
Overall Study	STARTED	Endo-HDR	5
Overall Study	COMPLETED	IMRT and Capecitabine	2
Overall Study	COMPLETED	Endo-HDR	5
Overall Study	NOT COMPLETED	IMRT and Capecitabine	2
Overall Study	NOT COMPLETED	Endo-HDR	0

Source ClinicalTrials.gov

Adverse events124

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	ANC elevated	Investigations	IMRT and Capecitabine	1	4
other	ANC elevated	Investigations	Endo-HDR	0	5
other	alanine amino transferase increased	Investigations	IMRT and Capecitabine	0	4
other	alanine amino transferase increased	Investigations	Endo-HDR	2	5
other	anemia	Blood and lymphatic system disorders	IMRT and Capecitabine	1	4
other	anemia	Blood and lymphatic system disorders	Endo-HDR	3	5
other	aspartate amino transferase increased	Investigations	IMRT and Capecitabine	0	4
other	aspartate amino transferase increased	Investigations	Endo-HDR	1	5
other	bilirubin increased	Investigations	IMRT and Capecitabine	1	4
other	bilirubin increased	Investigations	Endo-HDR	0	5

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IMRT and Capecitabine	0	4
Total, all-cause mortality	Endo-HDR	0	5
Total, other adverse events	IMRT and Capecitabine	4	4
Total, other adverse events	Endo-HDR	5	5
Total, serious adverse events	IMRT and Capecitabine	1	4
Total, serious adverse events	Endo-HDR	2	5

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons3

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

Comparison	Source
IMRT and Capecitabine vs Endo-HDR: Number of Patients With Pathologic Complete Response	Trial comparisons
IMRT and Capecitabine vs Endo-HDR: deaths from any cause	Trial comparisons
IMRT and Capecitabine vs Endo-HDR: 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.

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