Watchful waiting approach for rectal cancer treatment
A Multicenter Prospective National Cohort Study for Patients With Advanced Rectal Cancer - is it Possible to Induce Remission and Avoid Surgery - Watch and Wait?
This study is testing a 'Watch and Wait' approach for rectal cancer patients who have had treatment to see if they can avoid surgery if their cancer responds well.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Trial ID | NCT03125343 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients in Sweden with palpable rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN who are scheduled for neoadjuvant treatment.
Not a fit: Patients who are scheduled for immediate surgery after short course radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for surgery in patients who achieve a complete response, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise with similar watchful waiting approaches in rectal cancer, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gothenburg and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.