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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Primary Rectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5 years overall and disease free survival

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Dainius Pavalkis, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kaunas Medical University

Authority:

Lithuania: Kaunas University of Medicine

Study ID:

BE-2-48

NCT ID:

NCT00597311

Start Date:

January 2007

Completion Date:

January 2012

Related Keywords:

  • Primary Rectal Cancer
  • rectal cancer
  • radiotherapy
  • radiochemotherapy
  • Rectal Neoplasms

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