Trial · NCT00682786
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
NCT00682786, Phase 2, Completed, Washington University School of Medicine; results first posted 2014-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma. Trials, record NCT00682786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00682786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
- NCT number
- NCT00682786
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 135 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Rectal Carcinoma
- Interventions
- 5FU, Radiation, Surgery of resectable lesions, Irinotecan
- First posted
- 2008-05-22
- Last updated
- 2017-10-06
- Results first posted
- 2014-09-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Tumor Downstaging Compared With Historical Controls. | 1 year after enrollment | Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%. |
| Secondary | Complete Response Rates | 1 year after enrollment | Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0). Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0). pCR rate of historical controls is 8%-14%. |
| Secondary | Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation. | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy | The questionnaire is encouraged but not required. |
| Secondary | Determine Patient Fears and Expectations of Pharmacogenetics. | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy | The questionnaire is encouraged but not required. |
Source ClinicalTrials.gov
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Tumor Downstaging Compared With Historical Controls. | 1 year after enrollment | 8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rates | 1 year after enrollment | 8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician | percentage of participants | NUMBER |
| SECONDARY | Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation. | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy | The data was not collected for this outcome measure as the questionnaire was encouraged but not required. | ||
| SECONDARY | Determine Patient Fears and Expectations of Pharmacogenetics. | Prior to start of study treatment and 3-6 weeks post completion of radiation therapy | The data was not collected for this outcome measure as the questionnaire was encouraged but not required. | ||
| POST_HOC | Toxicities by Genotype Group (Good Risk Versus Poor Risk) | First day of treatment through 30 days after completion of surgery | Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included. | participants | NUMBER |
| POST_HOC | Overall Survival | 1 year, 2 years, and 3 years | Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included. | percentage of participants | NUMBER |
| POST_HOC | Relapse-free Survival | 1 year, 2 years, and 3 years | 14 patients in the Good Risk arm had metastatic rectal cancer at time of enrollment are not included in this analyses.~3 patients in the Poor Risk arm had metastatic rectal disease before surgery and are included in this analyses.~2 of the patients in the Good Risk arm and Poork Risk arm withdrew consent and are not included. | percentage of participants | NUMBER |
| POST_HOC | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group) | First day of treatment through 30 days after completion of surgery | 2 of the patients in the Good Risk arm withdrew consent and are not included. | participants | NUMBER |
| POST_HOC | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group) | First day of treatment through 30 days after completion of surgery | 2 of the patients in the Poor Risk arm withdrew consent and are not included. | participants | NUMBER |
| POST_HOC | Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group) | First day of treatment through 30 days after completion of surgery | 2 of the patients in the Good Risk arm withdrew consent and are not included. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Tumor Downstaging Compared With Historical Controls. | Good Risk (TYMS*2/*2, *2/*3, *2/*4) | 64.4 | 95% Confidence Interval 54.1 to 74.6 | percentage of participants | |
| Rate of Tumor Downstaging Compared With Historical Controls. | Poor Risk (TYMS*3/*3, *3/*4) | 64.5 | 95% Confidence Interval 43.7 to 78.9 | percentage of participants | |
| Complete Response Rates | Good Risk (TYMS*2/*2, *2/*3, *2/*4) | ypT0 | 20 | percentage of participants | |
| Complete Response Rates | Poor Risk (TYMS*3/*3, *3/*4) | ypT0 | 41.9 | percentage of participants | |
| Complete Response Rates | Good Risk (TYMS*2/*2, *2/*3, *2/*4) | pCR | 18.9 | percentage of participants | |
| Complete Response Rates | Poor Risk (TYMS*3/*3, *3/*4) | pCR | 35.5 | percentage of participants | |
| Toxicities by Genotype Group (Good Risk Versus Poor Risk) | Good Risk (TYMS*2/*2, *2/*3, *2/*4) | Nausea | 0 | participants | |
| Toxicities by Genotype Group (Good Risk Versus Poor Risk) | Poor Risk (TYMS*3/*3, *3/*4) | Nausea | 1 | participants | |
| Toxicities by Genotype Group (Good Risk Versus Poor Risk) | Good Risk (TYMS*2/*2, *2/*3, *2/*4) | Vomiting | 0 | participants | |
| Toxicities by Genotype Group (Good Risk Versus Poor Risk) | Poor Risk (TYMS*3/*3, *3/*4) | Vomiting | 1 | participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 98 | |
| Overall Study | STARTED | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 37 | |
| Overall Study | COMPLETED | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 96 | |
| Overall Study | COMPLETED | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 34 | |
| Overall Study | NOT COMPLETED | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 2 | |
| Overall Study | NOT COMPLETED | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 3 |
Source ClinicalTrials.gov
Adverse events178
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 | Leukocytes (total WBC) | Investigations | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 30 | 96 | |
| other | Leukocytes (total WBC) | Investigations | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 20 | 35 | |
| other | Platelets | Investigations | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 12 | 96 | |
| other | Platelets | Investigations | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 1 | 35 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 66 | 96 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 30 | 35 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Investigations | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 8 | 96 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Investigations | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 11 | 35 | |
| other | Lymphopenia | Investigations | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 88 | 96 | |
| other | Lymphopenia | Investigations | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 32 | 35 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | ||
| Total, all-cause mortality | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | ||
| Total, other adverse events | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 96 | 96 |
| Total, other adverse events | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 35 | 35 |
| Total, serious adverse events | Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) | 16 | 96 |
| Total, serious adverse events | Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4) | 12 | 35 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4) vs Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4): serious adverse events |
Source 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.
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GET https://conductscience.org/api/trials/v1/NCT00682786/results?page=2