The Stockholm III Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer
NCT ID: NCT00904813
Last Updated: 2021-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
840 participants
INTERVENTIONAL
1998-11-30
2018-03-31
Brief Summary
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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.
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Detailed Description
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In the initial protocol patients were randomly assigned (1:1:1) between three different RT courses; 5x5 Gy with surgery within 1 week (SRT), 5x5 Gy with surgery after 4-8 weeks (SRT-delay) or 25x2 Gy during 5 weeks without concomitant chemotherapy and surgery after 4-8weeks (LRT-delay). After a protocol amendment on May 21, 1999, participating hospitals could choose to randomise patients to just the short-course radiotherapy arms (1:1) or to all three arms.
Randomisation was done by telephone by the Regional Cancer Centre in Stockholm, Sweden, after assessing inclusion and exclusion criteria. Computer generated randomisation lists were constructed by use of permuted block technique (block size of six for the three- arm randomisation, block size of four for the two-arm randomisation) and stratified by participating center. Investigators and patients were not masked to treatment.
Follow-up was recommended at 3-, 6- and 12 months after surgery, and yearly thereafter. Although follow-up according to national guidelines with a minimum follow-up at 1 and 3 years was allowed. Patient data was also collected from the Swedish ColoRectal Cancer Register (SCRCR) and medical records.
Primary outcome:
1\. Time to local recurrence.
Secondary outcomes:
1. Recurrence-free survival
2. Frequency of postoperative complications
3. Frequency of tumour regression
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. Short-course RT (5x5 Gy) + surgery within 1 week (SRT)
RT=Preoperative radiotherapy Gy=Gray
Short-course RT
Preoperative radiotherapy (RT) given 5 times 5 Gray during five consecutive days, preferably Monday - Friday, with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
2. Short-course RT (5x5 Gy) + surgery after 4-8 weeks (SRT-delay)
RT=Preoperative radiotherapy Gy= Gray
Short-course RT
Preoperative radiotherapy (RT) given 5 times 5 Gray during five consecutive days, preferably Monday - Friday, with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
3. Long-course RT (25x2 Gy) + surgery after 4-8 weeks (LRT-delay)
RT= Preoperative radiotherapy Gy= Gray
Long-course RT
Preoperative radiotherapy (RT) given 2 Gy in 25 fractions during 5 weeks, total dose 50 Gy with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
Interventions
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Short-course RT
Preoperative radiotherapy (RT) given 5 times 5 Gray during five consecutive days, preferably Monday - Friday, with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
Long-course RT
Preoperative radiotherapy (RT) given 2 Gy in 25 fractions during 5 weeks, total dose 50 Gy with a four-field box technique, including the primary tumour and the primary and secondary lymph nodes in the pelvis.
Eligibility Criteria
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Inclusion Criteria
* Planned for bowel resection with an abdominal procedure.
* Informed consent.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Swedish Cancer Society
OTHER
The Swedish Research Council
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Anna Martling
Professor, Senior Consultant Surgeon
Principal Investigators
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Anna Martling, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Mora Hospital
Mora, Dalarna County, Sweden
Danderyds Hospital
Danderyd, Stockholm County, Sweden
Norrtälje Hospital
Norrtälje, Stockholm County, Sweden
Södertälje Hospital
Södertälje, Stockholm County, Sweden
Eskilstuna Hospital
Eskilstuna, , Sweden
Falun Hospital
Falun, , Sweden
Gävle Sjukhus
Gävle, , Sweden
Helsingborg Hospital
Helsingborg, , Sweden
Linköping University Hospital
Linköping, , Sweden
MAS University Hospital
Malmo, , Sweden
Vrinnevi Hospital
Norrköping, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Ersta Hospital
Stockholm, , Sweden
South Hospital
Stockholm, , Sweden
St Görans Hospital
Stockholm, , Sweden
Norrlands Universitetssjukhus
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Visby Hospital
Visby, , Sweden
Countries
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References
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Pettersson D, Lorinc E, Holm T, Iversen H, Cedermark B, Glimelius B, Martling A. Tumour regression in the randomized Stockholm III Trial of radiotherapy regimens for rectal cancer. Br J Surg. 2015 Jul;102(8):972-8; discussion 978. doi: 10.1002/bjs.9811.
Pettersson D, Cedermark B, Holm T, Radu C, Pahlman L, Glimelius B, Martling A. Interim analysis of the Stockholm III trial of preoperative radiotherapy regimens for rectal cancer. Br J Surg. 2010 Apr;97(4):580-7. doi: 10.1002/bjs.6914.
Pettersson D, Glimelius B, Iversen H, Johansson H, Holm T, Martling A. Impaired postoperative leucocyte counts after preoperative radiotherapy for rectal cancer in the Stockholm III Trial. Br J Surg. 2013 Jun;100(7):969-75. doi: 10.1002/bjs.9117. Epub 2013 Apr 2.
Erlandsson J, Holm T, Pettersson D, Berglund A, Cedermark B, Radu C, Johansson H, Machado M, Hjern F, Hallbook O, Syk I, Glimelius B, Martling A. Optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Stockholm III): a multicentre, randomised, non-blinded, phase 3, non-inferiority trial. Lancet Oncol. 2017 Mar;18(3):336-346. doi: 10.1016/S1470-2045(17)30086-4. Epub 2017 Feb 10.
Erlandsson J, Lorinc E, Ahlberg M, Pettersson D, Holm T, Glimelius B, Martling A. Tumour regression after radiotherapy for rectal cancer - Results from the randomised Stockholm III trial. Radiother Oncol. 2019 Jun;135:178-186. doi: 10.1016/j.radonc.2019.03.016. Epub 2019 Apr 1.
Erlandsson J, Pettersson D, Glimelius B, Holm T, Martling A. Postoperative complications in relation to overall treatment time in patients with rectal cancer receiving neoadjuvant radiotherapy. Br J Surg. 2019 Aug;106(9):1248-1256. doi: 10.1002/bjs.11200. Epub 2019 Jun 14.
Other Identifiers
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98/240
Identifier Type: -
Identifier Source: org_study_id
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