It is possible to avoid surgery in a selected group of patients (palpable low and mid rectal tumours) with complete response after neoadjuvant (chemo)radiotherapy for rectal cancer with similar or better oncologic outcome at three years as compared with patients without complete response treated with surgery?
3-year disease free survival. Thus, this includes patients that have had regrowth and been operated for their tumour. Patients that have had metastastic surgery are included as well.
For the WoW part of the study all patients with rectal cancer that achieve complete response after neoadjuvant treatment evaluated at 6 weeks, 12 or 16 weeks (if signs of near complete response are present at first or second evaluation) according to the specified criteria above can be included in the Watch and Wait protocol. In detail this includes patients with:
In the biopsy substudy the aim is 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.
Patients not willing to participate will be treated according to local and national guidelines but will be offered to answer the same QoL questionnaires.
Patients will be included by the treating surgeon. Patients receive information and sign informed consent.
As soon as a patient has given informed consent this is communicated by phone to the secretariat at SSORG at a specific phone number, and then the treating surgeon receives a study number for the patient that will enable registration in the web-CRF without further identification.
Patients with complete response but with metastases where the clinician chooses to follow the patient according to the algorithm in the study are not formally included in the study but will be registered.
Aiming at including 200 patients.