Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00055601 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT00055601: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00055601 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055601, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of combination chemotherapy plus radiation therapy with or without surgery is more effective in treating bladder cancer. PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy regimens and radiation therapy with or without radical cystectomy in treating patients who have stage II or stage III bladder cancer.
Primary Outcome
Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 eva
Interventions
- DRUG Gemcitabine
- DRUG cisplatin
- DRUG paclitaxel
- DRUG fluorouracil
- RADIATION radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2002-12 |
| Est. Completion | 2018-05-14 |
| Phase | Phase 2 |
What the finished NCT00055601 record still lists
NCT00055601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 5 interventions - of which Gemcitabine is the first listed.
NCT00055601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00055601 about?
NCT00055601 is a clinical study titled "Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer". RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of combination chemotherapy plus radiation therapy with or without surge...
What is the current status of trial NCT00055601?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2002-12. Estimated completion is 2018-05-14.
What interventions are being tested in trial NCT00055601?
The interventions under investigation include: Gemcitabine (DRUG), cisplatin (DRUG), paclitaxel (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00055601?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00055601's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 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
- NCT03948490 · 97 participants · NA
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
- NCT04140487 · 97 participants · Phase 1
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
- NCT04196413 · 97 participants · Phase 1
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
- NCT05223816 · 97 participants · Phase 2
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
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