NCT00006094

Brief Summary

Drugs used in chemotherapy use 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. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

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

July 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

6.3 years

First QC Date

August 3, 2000

Last Update Submit

January 15, 2013

Conditions

Adenocarcinoma of the RectumStage II Rectal CancerStage III Rectal Cancer

Outcome Measures

Primary Outcomes (4)

  • The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas

    7 days

  • Progression-free survival

    Will be estimated using the Kaplan-Meier method.

    From protocol entry until documented progression of disease or death from any cause, assessed up to 5 years

  • Pathological complete response rate

    The new regimen will be considered worthy of further investigation if 5 or greater CR's are observed among the 25 patients treated at the MTD. Assuming the new regimen will result in a 30% CR rate, the probability of observing 5 or greater CR's in 25 patients studied is 0.91. For an underlying CR rate of 0.25 this probability is 0.79. The probability of observing 5 or greater CR's if the underlying CR rate is 0.10 is 0.10.

    Up to 5 years

  • Latent toxicities graded using the Common Toxicity Criteria (CTC) version 2.0

    Up to 5 years

Study Arms (1)

Treatment (oxaliplatin, fluorouracil, EBRT)

EXPERIMENTAL

Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatinDrug: fluorouracilRadiation: external beam radiation therapy

Interventions

oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (oxaliplatin, fluorouracil, EBRT)
fluorouracilDRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Treatment (oxaliplatin, fluorouracil, EBRT)
external beam radiation therapyRADIATION

Undergo external beam radiation therapy

Also known as: EBRT
Treatment (oxaliplatin, fluorouracil, EBRT)

Eligibility Criteria

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

You may qualify if:

  • Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
  • Locally advanced disease defined as any of the following:
  • Fixed or immovable tumor on physical exam
  • T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI
  • T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI
  • No distant metastatic disease
  • Performance status - ECOG 0-2
  • Granulocyte count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

OxaliplatinFluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David Ryan

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

July 1, 2000

Primary Completion

October 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)