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NCT00081289 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

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

Completed
Registry status
Phase 2
Development phase
146
Enrollment target

NCT00081289 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 146 participants.

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The verdict

NCT00081289, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
146 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 uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

Interventions

  • DRUG Oxaliplatin
  • RADIATION Radiation Therapy
  • DRUG Irinotecan
  • DRUG Capecitabine 1650 mg/m^2/day
  • DRUG Capecitabine 1200 mg/m^2/day

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2004-03
Est. Completion 2016-12
Phase Phase 2

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00081289

The ClinicalTrials.gov registry entry for NCT00081289 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

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

NCT00081289 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00081289 about?

NCT00081289 is a clinical study titled "Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer". RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that i...

What is the current status of trial NCT00081289?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2004-03. Estimated completion is 2016-12.

What interventions are being tested in trial NCT00081289?

The interventions under investigation include: Oxaliplatin (DRUG), Radiation Therapy (RADIATION), Irinotecan (DRUG), Capecitabine 1650 mg/m^2/day (DRUG), Capecitabine 1200 mg/m^2/day (DRUG).

Who is sponsoring clinical trial NCT00081289?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.