A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00122291

Enrollment

Registered

2005-07-22

Start date

2002-01-31

Completion date

Unknown

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Neoplasm Metastasis

Keywords

preoperative, chemotherapy, radiation therapy, rectal cancer, transmural rectal wall invasion, nodal metastasis

Brief summary

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Detailed description

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Interventions

DRUGCapecitabine

PROCEDUREPelvic radiation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

* Biopsy - proven rectal cancer * Transmural rectal wall invasion * Karnofsky performance status \>70 * Normal bone marrow, liver and kidney function

Exclusion criteria

* Distant metastases * Prior pelvic radiation * Inflammatory bowel disease * Severe ischemic heart disease * Anticoagulant therapy * Pregnancy

Design outcomes

Primary

Measure	Time frame
safety	—
response	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026