NCT00124488

Brief Summary

Standard treatment for non-operable cervix cancer is radiation and chemotherapy. This treatment combination can result in significant radiation side-effects involving the bladder, small bowel and rectum. To improve results with radiation/chemotherapy, higher radiation doses have been tried for cervix cancer patients. Results from using higher radiation doses show that cervix tumours may be better controlled, but the radiation side-effects are worsened. Intensity modulated radiotherapy (IMRT) and Tomotherapy are new radiation planning and delivery technologies which may allow for delivery of higher radiation doses with less damage to normal organs. The purpose of this project is to determine whether or not IMRT and/or Tomotherapy technology can produce radiation plans that deliver higher doses of radiation to the tumor and lower doses to normal organs when compared to standard radiation plans. The results from this project will provide the basis for possibly treating future cervix cancer patients with Tomotherapy and providing them with improved cure rates along with decreased rates of radiation side effects. No patients will be treated on this protocol, as the investigators plan to only compare radiation dose calculations from different treatment plans created for test cervix cancer cases. There will be absolutely no patient contact in this protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2005

Shorter than P25 for all trials

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

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

First QC Date

July 26, 2005

Last Update Submit

December 8, 2011

Conditions

Keywords

radiotherapy planningcomputer assisted radiotherapyconformal

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Squamous cell cervix cancer
  • Undergone planning computed tomography (CT) scan for radiotherapy planning
  • Treated with chemoradiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Publications (9)

  • Thomas GM. Concurrent chemotherapy and radiation for locally advanced cervical cancer: the new standard of care. Semin Radiat Oncol. 2000 Jan;10(1):44-50. doi: 10.1016/s1053-4296(00)80020-x.

    PMID: 10671658BACKGROUND
  • Girinsky T, Rey A, Roche B, Haie C, Gerbaulet A, Randrianarivello H, Chassagne D. Overall treatment time in advanced cervical carcinomas: a critical parameter in treatment outcome. Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1051-6. doi: 10.1016/0360-3016(93)90522-w.

    PMID: 8262826BACKGROUND
  • Fyles A, Keane TJ, Barton M, Simm J. The effect of treatment duration in the local control of cervix cancer. Radiother Oncol. 1992 Dec;25(4):273-9. doi: 10.1016/0167-8140(92)90247-r.

    PMID: 1480773BACKGROUND
  • Petereit DG, Sarkaria JN, Chappell R, Fowler JF, Hartmann TJ, Kinsella TJ, Stitt JA, Thomadsen BR, Buchler DA. The adverse effect of treatment prolongation in cervical carcinoma. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1301-7. doi: 10.1016/0360-3016(94)00635-X.

    PMID: 7635769BACKGROUND
  • Perez CA, Grigsby PW, Chao KS, Mutch DG, Lockett MA. Tumor size, irradiation dose, and long-term outcome of carcinoma of uterine cervix. Int J Radiat Oncol Biol Phys. 1998 May 1;41(2):307-17. doi: 10.1016/s0360-3016(98)00067-4.

    PMID: 9607346BACKGROUND
  • Kavanagh BD, Gieschen HL, Schmidt-Ullrich RK, Arthur D, Zwicker R, Kaufman N, Goplerud DR, Segreti EM, West RJ. A pilot study of concomitant boost accelerated superfractionated radiotherapy for stage III cancer of the uterine cervix. Int J Radiat Oncol Biol Phys. 1997 Jun 1;38(3):561-8. doi: 10.1016/s0360-3016(97)89484-9.

    PMID: 9231680BACKGROUND
  • MacLeod C, Bernshaw D, Leung S, Narayan K, Firth I. Accelerated hyperfractionated radiotherapy for locally advanced cervix cancer. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):519-24. doi: 10.1016/s0360-3016(99)00043-7.

    PMID: 10348280BACKGROUND
  • Viswanathan FR, Varghese C, Peedicayil A, Lakshmanan J, Narayan VP. Hyperfractionation in carcinoma of the cervix: tumor control and late bowel complications. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):653-6. doi: 10.1016/s0360-3016(99)00245-x.

    PMID: 10524419BACKGROUND
  • Nutting C, Dearnaley DP, Webb S. Intensity modulated radiation therapy: a clinical review. Br J Radiol. 2000 May;73(869):459-69. doi: 10.1259/bjr.73.869.10884741.

    PMID: 10884741BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Don Yee, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

June 1, 2005

Study Completion

November 1, 2005

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations