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NCT00003596 · ClinicalTrials.gov registry record · Phase 3

Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

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

Completed
Registry status
Phase 3
Development phase
682
Enrollment target

NCT00003596: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.

NCT00003596 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 682 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003596, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
682 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer. PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer.

Interventions

  • DRUG cisplatin
  • DRUG fluorouracil
  • RADIATION radiation therapy
  • DRUG mitomycin C

Trial Details

FieldValue
Enrollment Target 682 participants
Start Date 1998-10
Est. Completion 2016-12
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00003596 record still lists

NCT00003596 is an interventional study that assigns participants to a tested intervention. The registered 682 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 (12% lower).

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

NCT00003596 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003596 about?

NCT00003596 is a clinical study titled "Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation thera...

What is the current status of trial NCT00003596?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 682 participants. The study started on 1998-10. Estimated completion is 2016-12.

What interventions are being tested in trial NCT00003596?

The interventions under investigation include: cisplatin (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION), mitomycin C (DRUG).

Who is sponsoring clinical trial NCT00003596?

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 NCT00003596's enrollment target sits among peer trials

682 529th of 2000 higher than 1,471 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 NCT00003596, the US trial registry maintained by the National Library of Medicine. NCT00003596 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.