Watch and Wait as Treatment for Patients With Rectal Cancer

Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Apr 21, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment option called "Watch and Wait" for patients with certain types of rectal cancer. Specifically, it focuses on patients who have rectal tumors that can be felt during a physical exam and are staged as cT4bNX or have specific characteristics on MRI scans. Instead of undergoing immediate surgery, these patients will receive a type of radiation treatment for a short period, followed by a waiting period of 6 to 8 weeks before any surgical decisions are made. The goal is to see if the cancer responds completely to the treatment during this waiting time, allowing for a potentially less invasive approach.

To be eligible for this trial, participants must be adults, typically aged between 65 and 74, with palpable rectal cancer that meets the specific criteria outlined. They must also be open to participating after receiving information about the study. During the trial, participants can expect regular check-ups and assessments to monitor their cancer's response to the initial treatment. It's important to note that patients who are not able to provide consent, have non-palpable tumors, or have certain medical conditions that prevent MRI scans will not be included in the study. This trial offers an exciting opportunity to explore a less aggressive treatment approach for rectal cancer, which may benefit some patients significantly.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • No informed consent received for participation.
• • 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.
• • Contraindication for MRI such as presence of non compatible metallic implants or claustrophobia.