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NCT00655876 · ClinicalTrials.gov registry record · Phase 3

Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

A Phase 3 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
344
Enrollment target

NCT00655876: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.

NCT00655876 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 344 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00655876, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
344 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Primary Outcome

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.

Interventions

  • DRUG cetuximab
  • DRUG cisplatin
  • DRUG paclitaxel
  • RADIATION radiation therapy

Trial Details

FieldValue
Enrollment Target 344 participants
Start Date 2008-06
Est. Completion 2022-05-20
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00655876 record still lists

NCT00655876 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 4 interventions - of which cetuximab is the first listed.

NCT00655876 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00655876 about?

NCT00655876 is a clinical study titled "Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer". RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, c...

What is the current status of trial NCT00655876?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 344 participants. The study started on 2008-06. Estimated completion is 2022-05-20.

What interventions are being tested in trial NCT00655876?

The interventions under investigation include: cetuximab (DRUG), cisplatin (DRUG), paclitaxel (DRUG), radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00655876?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00655876's enrollment target sits among peer trials

344 1050th of 2000 higher than 950 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00655876, the US trial registry maintained by the National Library of Medicine. NCT00655876 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.