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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Swedish Cancer Society
The Swedish Research Council
Information provided by (Responsible Party):
Anna Martling, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00904813
First received: May 19, 2009
Last updated: June 27, 2014
Last verified: June 2014
  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 2
Phase 3

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.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • time to recurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • acute and late toxicity [ Time Frame: 30 days and 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 840
Study Start Date: November 1998
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (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.

Detailed Description:

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904813

Locations
Sweden
Mora and Falun Hospital
Mora, Falun, Dalarna, Sweden
Danderyds Hospital
Danderyd, Stockholm, Sweden
Norrtälje Hospital
Norrtälje, Stockholm, Sweden
Södertälje Hospital
Södertälje, Stockholm, Sweden
Eskilstuna Hospital
Eskilstuna, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Linköping University Hospital
Linköping, Sweden
MAS University Hospital
Malmö, Sweden
Vrinnevi Hospital
Norrköping, Sweden
Gastrocentrum Kirurgi, Karolinska University Hospital
Stockholm, Sweden, 17176
St Görans Hospital
Stockholm, Sweden
South Hospital
Stockholm, Sweden
Ersta Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Visby Hospital
Visby, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Cancer Society
The Swedish Research Council
Investigators
Principal Investigator: Anna Martling, PhD Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Martling, Associate Professor, Senior Consultant Surgeon, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00904813     History of Changes
Other Study ID Numbers: 98/240
Study First Received: May 19, 2009
Last Updated: June 27, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Rectal cancer
Preoperative radiotherapy
Timing of Surgery
Prognosis

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 19, 2014