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NCT02935309 · ClinicalTrials.gov registry record · Phase 1
Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02935309: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02935309 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02935309, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This research study is designed to see if Capecitabine and Lenvatinib in combination with external radiation therapy are effective in treating locally advanced rectal adenocarcinoma in patients who have not yet had surgery, and what the best dosage is.
Primary Outcome
MTD of lenvatinib used in combination with capecitabine and external beam radiation as neoadjuvant therapy for patients with locally advanced rectal carcinoma. The MTD of lenvatinib will be defined as the highest dose level at which no more than 1 out of 6 participants experiences dose-limiting toxicity (DLT). DLT: Any of the hematology or non-hematologic toxicities noted in Table 3 of the protocol, considered to be at least possibly related to lenvatinib and/or capecitabine.
Interventions
- DRUG Capecitabine
- DRUG Lenvatinib
- RADIATION External Radiation Therapy (XRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-10-14 |
| Est. Completion | 2020-05-14 |
| Phase | Phase 1 |
What the finished NCT02935309 record still lists
NCT02935309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT02935309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02935309 about?
NCT02935309 is a clinical study titled "Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma". This research study is designed to see if Capecitabine and Lenvatinib in combination with external radiation therapy are effective in treating locally advanced rectal adenocarcinoma in patients who have not yet had surgery, and what the best dosage is.
What is the current status of trial NCT02935309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-10-14. Estimated completion is 2020-05-14.
What interventions are being tested in trial NCT02935309?
The interventions under investigation include: Capecitabine (DRUG), Lenvatinib (DRUG), External Radiation Therapy (XRT) (RADIATION).
Who is sponsoring clinical trial NCT02935309?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02935309's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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