Trial · NCT03300544
Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer
NCT03300544, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2024-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer. Trials, record NCT03300544. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03300544
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer
- NCT number
- NCT03300544
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Rectal Adenocarcinoma, Stage III Rectal Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Rectal Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7
- Interventions
- Capecitabine, Fluorouracil, Leucovorin, Oxaliplatin, Radiation Therapy, Talimogene Laherparepvec
- First posted
- 2017-10-03
- Last updated
- 2024-05-23
- Results first posted
- 2024-05-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) of Talimogene Laherparepvec in Combination With Chemotherapy and Radiation in Rectal Cancer. | 4 weeks after surgery | Assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0. |
| Secondary | To Establish Safety and Feasibility of the Combination | 4 weeks after surgery | Feasibility will be reported in all patients who have started therapy as percent of planned dose intensity. The scale for dose intensity will range from 0 - 100% with a higher score being better. The result will be reported using descriptive statistics. |
| Secondary | Determine the Neoadjuvant Rectal (NAR) Score of Talimogene Laherparepvec With Chemotherapy and Radiation. | 4 weeks after surgery | The NAR score has been validated in clinical trials as a surrogate endpoint for overall survival. The score is designed to be particularly sensitive to changes in factors that are affected by neoadjuvant. NAR is calculated based on the clinical T stage (cT), pathological T (pT) and pN stages as: NAR = \[5pN- 3 (cT- pT) + 12\] \^2 / 9.61 and will be reported using descriptive statistics Scale: The NAR score is a pseudo-continuous variable with 24 possible discrete scores from 0 to 100 with higher scores representing a poorer prognosis. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determination of Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) of Talimogene Laherparepvec in Combination With Chemotherapy and Radiation in Rectal Cancer. | 4 weeks after surgery | Poor enrollment due to COVID-19 and change in standard of care led to discontinuation of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Establish Safety and Feasibility of the Combination | 4 weeks after surgery | Poor enrollment due to COVID-19 and change in standard of care led to discontinuation of the study | percentage of dose intensity | MEDIAN |
| SECONDARY | Determine the Neoadjuvant Rectal (NAR) Score of Talimogene Laherparepvec With Chemotherapy and Radiation. | 4 weeks after surgery | Poor enrollment due to COVID-19 and change in standard of care led to discontinuation of the study | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determination of Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) of Talimogene Laherparepvec in Combination With Chemotherapy and Radiation in Rectal Cancer. | Treatment (T-VEC, Capecitabine, Chemoradiation) | 3 | Participants | ||
| To Establish Safety and Feasibility of the Combination | Treatment (T-VEC, Capecitabine, Chemoradiation) | 99.5 | Full Range 99 to 100 | percentage of dose intensity | |
| Determine the Neoadjuvant Rectal (NAR) Score of Talimogene Laherparepvec With Chemotherapy and Radiation. | Treatment (T-VEC, Capecitabine, Chemoradiation) | 30.07 | Full Range 0.93 to 37.56 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Talimogene Laherparepvec + FOLFOX + Short Course RT | 3 | |
| Overall Study | COMPLETED | Talimogene Laherparepvec + FOLFOX + Short Course RT | 3 | |
| Overall Study | NOT COMPLETED | Talimogene Laherparepvec + FOLFOX + Short Course RT | 0 |
Source ClinicalTrials.gov
Adverse events13
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 | Urinary frequency | Renal and urinary disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Pain (lower back) | Musculoskeletal and connective tissue disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Urinary Tract Infection | Renal and urinary disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Anemia | Investigations | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | ANC low | Investigations | Treatment (T-VEC, Capecitabine, Chemoradiation) | 2 | 3 | |
| other | Platelet count low | Investigations | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Constipation | Gastrointestinal disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Headache | Nervous system disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 | |
| other | Anxiety | Nervous system disorders | Treatment (T-VEC, Capecitabine, Chemoradiation) | 1 | 3 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (T-VEC, Capecitabine, Chemoradiation) | 0 | 3 |
| Total, other adverse events | Treatment (T-VEC, Capecitabine, Chemoradiation) | 3 | 3 |
| Total, serious adverse events | Treatment (T-VEC, Capecitabine, Chemoradiation) | 0 | 3 |
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 |
|---|---|---|---|---|---|
| UM1CA186688 | Texas EXperimental Cancer Therapeutics Network - TEX CTN | MERIC-BERNSTAM, FUNDA; SARANTOPOULOS, JOHN; YAO, JAMES C | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
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.
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/NCT03300544
GET https://conductscience.org/api/trials/v1/NCT03300544/registered