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| Sponsor: | Karolinska Institutet |
|---|---|
| Collaborators: |
Swedish Cancer Society Stockholm County Council, Sweden The Stockholm Cancer Society |
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00904813 |
Purpose
There are theoretical reasons to believe that radiotherapy (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 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 multicentre 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Radiation: Preoperative radiotherapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer, Stockholm III. |
| Estimated Enrollment: | 840 |
| Study Start Date: | November 1998 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1. RT 5x5 Gy + surgery within 1 week
RT=Preoperative radiotherapy Gy=Gray
|
Radiation: Preoperative radiotherapy
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.
|
|
Active Comparator: 2.RT 5x5 Gy + surgery after 4-8 weeks
RT=radiotherapy Gy= Gray
|
Radiation: Preoperative radiotherapy
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.
|
|
Active Comparator: 3.RT 25x2 Gy + surgery after 4-8 weeks
RT= radiotherapy Gy= Gray
|
Radiation: Preoperative radiotherapy
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anna Martling, PhD | +46851772802 | anna.martling@karolinska.se |
| Contact: Björn Cedermark, PhD |
| Sweden | |
| Mora and Falun Hospital | Recruiting |
| Mora, Falun, Dalarna, Sweden | |
| Contact: Anders Nihlberg, MD | |
| Danderyds Hospital | Recruiting |
| Danderyd, Stockholm, Sweden | |
| Contact: Claes Johansson, MD PhD | |
| Norrtälje Hospital | Recruiting |
| Norrtälje, Stockholm, Sweden | |
| Contact: Nils Lundqvist, MD PhD | |
| Södertälje Hospital | Recruiting |
| Södertälje, Stockholm, Sweden | |
| Contact: Ulrik Lindforss, MD PhD | |
| Linköping University Hospital | Recruiting |
| Linköping, Sweden | |
| Contact: Disa Kalman, MD | |
| MAS University Hospital | Recruiting |
| Malmö, Sweden | |
| Contact: Ingvar Syk, MD PhD | |
| South Hospital | Recruiting |
| Stockholm, Sweden | |
| Contact: Yngve Raab, MD PhD | |
| St Görans Hospital | Recruiting |
| Stockholm, Sweden | |
| Contact: Johan Dahlén, MD PhD | |
| Gastrocentrum Kirurgi, Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 17176 | |
| Contact: Anna Martling, PhD +46851772802 | |
| Principal Investigator: Anna Martling, MD PhD | |
| Ersta Hospital | Recruiting |
| Stockholm, Sweden | |
| Contact: Mikael Machado, MD PhD | |
| Uppsala University Hospital | Recruiting |
| Uppsala, Sweden | |
| Contact: Lars Påhlman, Professor | |
| Principal Investigator: Lars Påhlman, Professor | |
| Sub-Investigator: Bengt Glimelius, Professor | |
| Principal Investigator: | Anna Martling, PhD | Karolinska Institutet |
More Information
| Responsible Party: | Anna Martling M.D Ph.D, Stockholm Colorectal Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00904813 History of Changes |
| Other Study ID Numbers: | 98/240 |
| Study First Received: | May 19, 2009 |
| Last Updated: | May 11, 2011 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
|
Rectal cancer Preoperative radiotherapy Timing of Surgery Prognosis |
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
