Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatments preoperative radiotherapy
Phase phase 2/phase 3
Sponsor Karolinska Institutet
Collaborator Swedish Cancer Society
Start date November 1998
End date January 2017
Trial size 840 participants
Trial identifier NCT00904813, 98/240

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
RT=Preoperative radiotherapy Gy=Gray
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)
RT=radiotherapy Gy= Gray
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)
RT= radiotherapy Gy= Gray
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.

Primary Outcomes

Measure
time to recurrence
time frame: 3 years

Secondary Outcomes

Measure
acute and late toxicity
time frame: 30 days and 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Randomized Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer, Stockholm III.
Principal investigator Anna Martling, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.