NCT00754078

Brief Summary

The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

8.1 years

First QC Date

September 15, 2008

Last Update Submit

July 4, 2016

Conditions

Anal Canal Cancer

Keywords

tomotherapy

Outcome Measures

Primary Outcomes (1)

  • Acute Toxicity and Quality of LIfe

    3 months

Secondary Outcomes (2)

  • colostomy-free survival and/or overall survival

    3 and 5 years

  • Local Recurrence

    3 and 5 years

Study Arms (1)

1

OTHER

anal cancer patients treated with tomotherapy and chemotherapy

Radiation: Tomotherapy

Interventions

TomotherapyRADIATION

30 fractions of tomotherapy treatment

1

Eligibility Criteria

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

You may qualify if:

  • Patient should have histologically proven primary squamous carcinoma or its variant
  • No history of prior malignancy.
  • Patients must be free of metastatic disease out of pelvis at the time of diagnosis
  • Patients must be at least 18 years of age
  • Performance status 0, 1 or 2 ECOG
  • T stage 2-4, Any N, stage MO
  • Patient should be eligible for concomitant chemotherapy
  • Informed written consent required to participate

You may not qualify if:

  • Prior radiation to pelvis
  • Pregnant or lactating
  • prior surgical treatment for anal cancer other than biopsy
  • prior surgical or chemotherapy treatment for anal cancer
  • T1 tumours (2cm) or evidence of distant mets
  • comorbid medical conditions precluding radical treatment at the discretion of oncologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Anal Canal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Kurian J Joseph, MD, FRCPC

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 17, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

CA(1)