Health TrialsbyHealthPanel

Watch and Wait as Treatment for Patients With Rectal Cancer

ConditionRectal Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

cT4bNX

anycTanycN and cMRF+ anycTanycN and lateral lymph nodes on MRI

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • endoscopy

    Procedure/Surgery

    Continuous follow-up. All patients with complete response will be followed for ten years. Details from the follow-up schedule will be registered in clinical record forms including information on the endoscopic findings, MRI findings and digital examination. They will be followed ever third month for the first two years as follows: * PET-CT is optional, but can be performed at inclusion * Pelvic MRI including diffusion weighted imaging according to appendix C. * Clinical examination * Endoscopy (flexible sigmoidoskopy) with photodocumentation * CEA After two years the patients will be followed every six month with: * Pelvic MRI including diffusion weighted imaging according to appendix as at baseline * Clinical examination * Endoscopy with photodocumentation * CEA

  • Surgery

    Procedure/Surgery

    Surgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy

  • MRI

    Device

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: No surgeryExperimental treatment 2 interventions
Group B: SurgeryActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

3-year disease free survival.

Thus this includes patients that have had regrowth and been operated for their tumour. Includes metastastic surgery as well

Time frame
3 years

Secondary outcomes

1

Percentage re-growth during follow-up

Endoscopic or MRI indication of regrowth

Time frame
10 years
2

Local recurrence after salvage surgery due to regrowth

Local recurrence as shown by MRI, endoscopy or digital examination

Time frame
10 years
3

Results after surgery for re-growth

Complications and mortality after surgery

Time frame
10 years
4

Long-term survival

Overall survival

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahlgrenska University Hospital

Lead sponsor

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
Apply now