Watch and wait instead of surgery for advanced rectal cancer
Studies whether rectal cancer can be controlled without surgery, watching closely after treatment.
Plain-language title generated from the registry record
Registry title: Watch and Wait as Treatment for Patients With Rectal Cancer
Key facts
- Where
- Gothenburg and Stockholm, SwedenSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in Sweden with rectal cancer that can be felt by finger exam and is planned for radiotherapy or chemoradiotherapy before surgery. The aim is to see whether some can avoid surgery.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Rectal cancer in the middle or low rectum that can be felt by finger exam. Staged cT4bNX, or any cT with any cN and cMRF+, or lateral lymph nodes on MRI.
- Earlier treatment
- Planned for 5x5 Gy radiotherapy with a 6-8 week wait before surgery, or for planned chemoradiotherapy before surgery. Patients planned for short course radiotherapy with immediate surgery cannot join.
Main reasons for not taking part
- No informed consent given
- Rectal cancer that cannot be felt by finger exam (10-15 cm (3.9–5.9 in))
- Cannot have an MRI, for example metal implants that do not fit MRI or claustrophobia
- Planned for short course radiotherapy with immediate surgery
Read by machine on 9 November 2026.
Where in Sweden
- Dept. of Surgery, Sahlgrenska University Hospital/OstraGothenburg, SwedenTaking people
- Karolinska InstitutetStockholm, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sahlgrenska University Hospital
- Trial code
- NCT03125343
- Record updated
- 7 November 2023
- Original description
A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.Read full original descriptionShow less
A Multicenter Prospective National Cohort Study for Patients With Advanced Rectal Cancer - is it Possible to Induce Remission and Avoid Surgery - Watch and Wait?
A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.
Inclusion: All patients in Sweden with a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI considered appropriate for 5x5 Gy and 6-8 weeks of wait prior to surgery according to Stockholm III (28) or a palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI a planned schedule for CRT according to the Swedish National Program for rectal cancer scheduled for neoadjuvant therapy are possible to include; The study includes two parts, where part one is optional in including hospitals. The aim of the biopsy substudy to identify tumour and plasma markers for complete response, thus all patients that will receive (chemo)radiotherapy in the neoadjuvant setting are included to provide a control for the biopsies; For the WoW part of the study all patients that achieve complete response after neoadjuvant treatment according to the specified criteria above can be included in the Watch and Wait protocol. In detail this includes patients with:; Midrectal or low rectal cancers that are palpable and considered with an indication of 5x5 Gy and long wait (6-8 weeks) (the indication for waiting may be logistics, co-morbidity, advanced age):; cT4bNX; anycTanycN and cMRF+ anycTanycN and lateral lymph nodes on MRI.
Exclusion: No informed consent received for participation; Contraindication for MRI such as presence of non compatible metallic implants or claustrophobia; Patients with rectal cancer that is scheduled for (chemo) radiotherapy but is not palpable during rectal examination (10-15 cm) as this cannot be examined by digital examination and followed as scheduled.