Watchful waiting approach for rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a 'Watch and Wait' strategy for patients with rectal cancer who have undergone neoadjuvant treatment with (chemo)radiotherapy. Patients with a complete or near-complete response after treatment will be monitored without immediate surgery, while those who do not respond will proceed to surgery as planned. The study includes quality of life assessments and aims to identify biomarkers associated with treatment response. Participants will be followed at regional university hospitals for ongoing evaluation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dept. of Surgery, Sahlgrenska University Hospital/Ostra
  Gothenburg, Sweden Recruiting
• Karolinska Institutet
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Eva Angenete, M.D., Ph.D. — Sahlgrenska Academy at Gothenburg University
• Study coordinator: Eva Angenete, M.D., Ph.D.
• Email: eva.angenete@vgregion.se

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.