NCT00232453

Brief Summary

There is no established standard preoperative treatment in rectal cancer. Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy. The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity. It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

3.8 years

First QC Date

October 3, 2005

Last Update Submit

February 11, 2011

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy

Interventions

Combined Radiation and ChemotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven adenocarcinoma of the rectum
  • Performance status \<2 (ECOG, appendix II)
  • Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis

You may not qualify if:

  • Prior pelvic irradiation
  • Inflammatory bowel disease
  • Evidence of distant metastasis
  • Performance status \>2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • James Brierley, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

March 1, 2001

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

CA(1)