Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00611858 · ClinicalTrials.gov registry record · Phase 2
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00611858: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00611858 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00611858, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given with 5-FU and radiation therapy.
Primary Outcome
Pathological complete response (pCR) rate is the percentage of participants who achieve pCR defined as no evidence of tumor cells in the surgical specimen including the lymph nodes (down-staging to pathological T0, N0 after planned neoadjuvant therapy).
Interventions
- DRUG Cetuximab
- DRUG 5-Fluorouracil
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2008-05 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
Why NCT00611858 stopped before completion
NCT00611858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT00611858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00611858 about?
NCT00611858 is a clinical study titled "Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer". The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves th...
What is the current status of trial NCT00611858?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2008-05. Estimated completion is 2016-09.
What interventions are being tested in trial NCT00611858?
The interventions under investigation include: Cetuximab (DRUG), 5-Fluorouracil (DRUG), Radiation (RADIATION).
Who is sponsoring clinical trial NCT00611858?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00611858's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia