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NCT00113399 · ClinicalTrials.gov registry record · Phase 3

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

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

Terminated
Registry status
Phase 3
Development phase
15
Enrollment target

NCT00113399: Clinical Trial Phase 3 study, sponsored by Radiation Therapy Oncology Group.

NCT00113399 is a Phase 3 study that was terminated before completion, run by Radiation Therapy Oncology Group. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00113399, a Phase 3 study, was terminated before completion, sponsored by Radiation Therapy Oncology Group.

TERMINATED
Registry status
Phase 3
Development phase
15 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.

Interventions

  • DRUG cisplatin
  • DRUG docetaxel
  • DRUG paclitaxel
  • DRUG fluorouracil
  • BIOLOGICAL filgrastim

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2005-04
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

Why NCT00113399 stopped before completion

NCT00113399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.

NCT00113399 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00113399 about?

NCT00113399 is a clinical study titled "Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation ther...

What is the current status of trial NCT00113399?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2005-04.

What interventions are being tested in trial NCT00113399?

The interventions under investigation include: cisplatin (DRUG), docetaxel (DRUG), paclitaxel (DRUG), fluorouracil (DRUG), filgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT00113399?

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 NCT00113399's enrollment target sits among peer trials

15 1977th of 2000 higher than 18 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 NCT00113399, the US trial registry maintained by the National Library of Medicine. NCT00113399 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.