N/A
Completed N=840
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
| Outcome | Result | p-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
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.