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NCT00777491 · ClinicalTrials.gov registry record · Phase 2

Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery

A Phase 2 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT00777491: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.

NCT00777491 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00777491, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, 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. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation therapy regimens to see how they work in treating patients with stage II or stage III bladder cancer that was removed by surgery.

Primary Outcome

Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone.

Interventions

  • DRUG induction cisplatin
  • DRUG induction 5-fluorouracil
  • DRUG induction gemcitabine
  • RADIATION Induction BID radiation therapy
  • RADIATION Induction QD radiation therapy

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2008-12
Est. Completion 2022-05-20
Phase Phase 2
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00777491 record still lists

NCT00777491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

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

NCT00777491 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00777491 about?

NCT00777491 is a clinical study titled "Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery". RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, 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. Giving chemotherapy togethe...

What is the current status of trial NCT00777491?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2008-12. Estimated completion is 2022-05-20.

What interventions are being tested in trial NCT00777491?

The interventions under investigation include: induction cisplatin (DRUG), induction 5-fluorouracil (DRUG), induction gemcitabine (DRUG), Induction BID radiation therapy (RADIATION), Induction QD radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00777491?

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 NCT00777491's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 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

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Source: ClinicalTrials.gov NCT00777491, the US trial registry maintained by the National Library of Medicine. NCT00777491 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.