Trial · NCT03904043
Non-Operative Management and Early Response Assessment in Rectal Cancer
NCT03904043, Not applicable, Completed, Washington University School of Medicine; results first posted 2025-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-Operative Management and Early Response Assessment in Rectal Cancer. Trials, record NCT03904043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03904043
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Operative Management and Early Response Assessment in Rectal Cancer
- NCT number
- NCT03904043
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 63 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Adenocarcinoma of the Lower Rectum
- Interventions
- Radiation therapy, FOLFOX regimen, CAPOX regimen
- First posted
- 2019-04-04
- Last updated
- 2026-05-01
- Results first posted
- 2025-06-11
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Complete Response Rate | Completion of treatment (estimated to be 22 weeks) | \- Criteria for clinical complete response: * No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer * No palpable tumor on DRE * No radiographic evidence of tumor on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) |
| Secondary | Progression-free Survival (PFS) | At 2 years | * Criteria for progressive disease: * Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm) * New metastatic disease * PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up. |
| Secondary | Incidence of Any Grade 3 or Higher Toxicity During Treatment | From start of treatment through the completion of treatment (estimated to be 22 weeks) | \- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Secondary | Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity | At 1 year after the start of radiation | \- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being) | Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy | * Physical Well-Being section of the FACT-C questionnaire consists of 7 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being) | Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy | * Social/Family Well-Being section of the FACT-C questionnaire consists of 7 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being) | Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy | * Emotional Well-Being section of the FACT-C questionnaire consists of 6 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-24. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being) | Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy | * Functional Well-Being section of the FACT-C questionnaire consists of 7 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale) | Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy | * Colorectal Cancer Subscale section of the FACT-C questionnaire consists of 7 scored questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score) | Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy | * The FACT-G total score is calculated by adding the Physical Well Being subscale score, Social/Family Well Being subscale score, Emotional Well Being subscale score, and Functional Well Being subscale score * Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score ranges from 0-108. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Complete Response Rate | Completion of treatment (estimated to be 22 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | At 2 years | |||
| SECONDARY | Incidence of Any Grade 3 or Higher Toxicity During Treatment | From start of treatment through the completion of treatment (estimated to be 22 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity | At 1 year after the start of radiation | |||
| SECONDARY | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | 10-14 months after radiation therapy | |||
| SECONDARY | Organ Preservation Rate | At 1 year | |||
| SECONDARY | Organ Preservation Rate | At 2 years |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Complete Response Rate | Radiation + FOLFOX | 36 | Participants | ||
| Clinical Complete Response Rate | Radiation + CAPOX | 2 | Participants | ||
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + FOLFOX | Abdominal pain | 0 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + CAPOX | Abdominal pain | 1 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + FOLFOX | Acidosis | 1 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + CAPOX | Acidosis | 0 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + FOLFOX | Alanine aminotransferase increased | 2 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + CAPOX | Alanine aminotransferase increased | 0 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + FOLFOX | Anal pain | 0 | Participants | |
| Incidence of Any Grade 3 or Higher Toxicity During Treatment | Radiation + CAPOX | Anal pain | 1 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation + FOLFOX | 55 | |
| Overall Study | STARTED | Radiation + CAPOX | 8 | |
| Overall Study | COMPLETED | Radiation + FOLFOX | 51 | |
| Overall Study | COMPLETED | Radiation + CAPOX | 7 | |
| Overall Study | NOT COMPLETED | Radiation + FOLFOX | 4 | |
| Overall Study | NOT COMPLETED | Radiation + CAPOX | 1 |
Source ClinicalTrials.gov
Adverse events122
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 | Anemia | Blood and lymphatic system disorders | Radiation + FOLFOX | 1 | 54 | |
| other | Anemia | Blood and lymphatic system disorders | Radiation + CAPOX | 1 | 8 | |
| other | Congestive heart failure | Cardiac disorders | Radiation + FOLFOX | 1 | 54 | |
| other | Congestive heart failure | Cardiac disorders | Radiation + CAPOX | 0 | 8 | |
| other | Anal pain | Gastrointestinal disorders | Radiation + FOLFOX | 0 | 54 | |
| other | Anal pain | Gastrointestinal disorders | Radiation + CAPOX | 1 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | Radiation + FOLFOX | 4 | 54 | |
| other | Diarrhea | Gastrointestinal disorders | Radiation + CAPOX | 1 | 8 | |
| other | Proctitis | Gastrointestinal disorders | Radiation + FOLFOX | 2 | 54 | |
| other | Proctitis | Gastrointestinal disorders | Radiation + CAPOX | 1 | 8 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation + FOLFOX | 1 | 54 |
| Total, all-cause mortality | Radiation + CAPOX | 0 | 8 |
| Total, other adverse events | Radiation + FOLFOX | 28 | 54 |
| Total, other adverse events | Radiation + CAPOX | 5 | 8 |
| Total, serious adverse events | Radiation + FOLFOX | 21 | 54 |
| Total, serious adverse events | Radiation + CAPOX | 2 | 8 |
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 |
|---|---|
| Radiation + FOLFOX vs Radiation + CAPOX: deaths from any cause | Trial comparisons |
| Radiation + FOLFOX vs Radiation + CAPOX: Clinical Complete Response Rate | Trial comparisons |
| Radiation + FOLFOX vs Radiation + CAPOX: 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.
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/NCT03904043
GET https://conductscience.org/api/trials/v1/NCT03904043/results?page=2