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N/A Completed N=840 Randomized Treatment

The Stockholm III Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer

Source: ClinicalTrials.gov NCT00904813 ↗
Enrolled (actual)
840
Serious AEs
3.4%
Results posted
Apr 2021
Primary outcomePrimary: Time to Local Recurrence. — 28.3; 22.1; 33.3; 35.1 months — p=0.52

Summary

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. There are theoretical reasons to believe that radiotherapy 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 patients with rectal cancer. In addition, the optimum timing of surgery after RT, with respect to postoperative morbidity, mortality and potential downsizing of the tumour is not known. To address these questions, a prospective randomized multicenter trial was initiated, the Stockholm III trial, in which patients with primarily resectable rectal cancer were randomized to short-course preoperative RT (5x5 Gy) followed by surgery within one week or after 4-8 weeks or long-course preoperative RT(25x2 Gy) followed by surgery after 4-8 weeks.

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Local Recurrence.
28.3; 22.1; 33.3; 35.1; 17.2; 33.4 0.52
SECONDARY
Number of Participants With Postoperative Complications in Relation to Preoperative Radiotherapy Regimen and Overall Treatment Time.
45; 138; 82; 63; 16; 28 0.289
SECONDARY
Tumour Regression Based on the Dworak Grading Scoring System
29; 20; 4; 233; 124; 42 0.046 sig

Eligibility Criteria

Inclusion Criteria

  • Biopsy confirmed clinically resectable rectal adenocarcinoma within 15 cm from the anal verge
  • Planned for bowel resection with an abdominal procedure.
  • Informed consent.

Exclusion Criteria

  • Distant metastases
  • Locally advanced unresectable tumors
  • Planned for local excision
  • Previous radiotherapy to the abdominal or pelvic region
  • Severe ischemic heart disease or symptoms of severe arteriosclerosis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00904813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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