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NCT03300544 · ClinicalTrials.gov registry record · Phase 1
Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03300544: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03300544 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03300544, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose and side effects of talimogene laherparepvec in combination with 5-fluorouracil, leucovorin, oxaliplatin, capecitabine, and chemoradiation before surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue and lymph nodes. Drugs used in immunotherapy, such as talimogene laherparepvec, may stimulate the body's immune system to fight tumor cells. Drugs used in chemotherapy, such as 5-fluorouracil, leucovorin, oxaliplatin, and capecitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving talimogene laherparepvec, 5-fluorouracil, leucovorin, oxaliplatin, and capecitabine and chemoradiation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
Assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- RADIATION Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2022-03-22 |
| Phase | Phase 1 |
Why NCT03300544 stopped before completion
NCT03300544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT03300544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03300544 about?
NCT03300544 is a clinical study titled "Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer". This phase I trial studies the best dose and side effects of talimogene laherparepvec in combination with 5-fluorouracil, leucovorin, oxaliplatin, capecitabine, and chemoradiation before surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue and lymph ...
What is the current status of trial NCT03300544?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-05-14. Estimated completion is 2022-03-22.
What interventions are being tested in trial NCT03300544?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03300544?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03300544's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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