Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

NCT ID: NCT00597311

Last Updated: 2008-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

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

2

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

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

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

Interventions

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radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaunas University of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kaunas University of Medicine

Principal Investigators

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Dainius Pavalkis, professor

Role: PRINCIPAL_INVESTIGATOR

Kaunas Medical University

Locations

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KMUH, surgery department

Kaunas, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Tadas Latkauskas

Role: CONTACT

+370 676 08901

Facility Contacts

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Tadas Latkauskas

Role: primary

+370 676 08901

References

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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.

Reference Type DERIVED
PMID: 27903247 (View on PubMed)

Other Identifiers

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137/2006

Identifier Type: -

Identifier Source: secondary_id

BE-2-48

Identifier Type: -

Identifier Source: org_study_id

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