NCT00597311

Brief Summary

Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.

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
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

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

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 18, 2008

Status Verified

January 1, 2008

Enrollment Period

5 years

First QC Date

January 9, 2008

Last Update Submit

January 9, 2008

Conditions

Primary Rectal Cancer

Keywords

rectal cancerradiotherapyradiochemotherapy

Outcome Measures

Primary Outcomes (2)

  • 5 years overall and disease free survival

    5 years

  • recurrence rate

    5 years

Secondary Outcomes (4)

  • pathological "complete response" and downstaging rates

    5 years

  • Impact on sphincter sparing operation rates

    5 years

  • morbidity and mortality rates

    5 years

  • Impact on quality of surgical resection

    5 years

Study Arms (2)

1

EXPERIMENTAL

preoperative short term radiation group 5x5 Gy and surgery after 6 weeks

Radiation: radiotherapy

2

EXPERIMENTAL

preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.

Radiation: radiotherapy

Interventions

radiotherapyRADIATION

1. Short term radiotherapy 5x5 Gy during 5 days 2. Chemoradiotherapy 50 Gy + 5Fu/Lv

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
  • less than 80 years old
  • no other cancer during 5 years period
  • compensate cardiovascular, pulmonary, hepatic and renal functions.

You may not qualify if:

  • stage I or IV rectal cancer
  • other cancer in 5 years period
  • radiotherapy or chemotherapy in anamnesis
  • not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
  • pregnancy or baby feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KMUH, surgery department

Kaunas, LT3000, Lithuania

RECRUITING

Related Publications (1)

  • Latkauskas T, Pauzas H, Kairevice L, Petrauskas A, Saladzinskas Z, Janciauskiene R, Gudaityte J, Lizdenis P, Svagzdys S, Tamelis A, Pavalkis D. Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial. BMC Cancer. 2016 Dec 1;16(1):927. doi: 10.1186/s12885-016-2959-9.

    PMID: 27903247DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Dainius Pavalkis, professor

    Kaunas Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tadas Latkauskas

CONTACT

+370 676 08901tadas.latkauskas@kmuk.lt

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 18, 2008

Record last verified: 2008-01

Locations

LI(1)