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A Prospective Randomized Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer, Stockholm III.


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

A Prospective Randomized Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer, Stockholm III.


Preoperative radiotherapy (RT) is recommended to many patients with localised rectal cancer,
not previously treated with pelvic RT. However, the optimum fractionation, the timing of
surgery and the best use of concomitant chemotherapy remains controversial. Short-course,
preoperative RT may induce both acute and late morbidity and has been claimed to cause more
morbidity than long-course preoperative RT. There are theoretical reasons to believe that RT
given in larger fractions during a shorter period of time might result in more late side
effects than giving a conventional, more protracted RT. In addition, the optimum timing of
surgery after RT, with respect to postoperative morbidity, mortality and potential
downsizing of the tumour is not known.


Inclusion Criteria:



- Biopsy confirmed clinically resectable rectal adenocarcinoma within 15 cm from the
anal verge

- Planned for bowel resection with an abdominal procedure.

Exclusion Criteria:

- Distant metastases

- Locally advanced unresectable tumors

- Planned for local excision

- Previous radiotherapy to the abdominal or pelvic region

- Severe ischemic heart disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to recurrence

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Anna Martling, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Institutet

Authority:

Sweden: The National Board of Health and Welfare

Study ID:

98/240

NCT ID:

NCT00904813

Start Date:

November 1998

Completion Date:

January 2018

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • Preoperative radiotherapy
  • Timing of Surgery
  • Prognosis
  • Rectal Neoplasms

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