Watch and Wait as Treatment for Patients With Rectal Cancer

NCT03125343 | Recruiting

• 1 other identifier: WoW
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rectal Neoplasms

Keywords

radiotherapy; chemotherapy; complete response

Outcome Measures

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

  3 years

Secondary Outcomes (8)

• Percentage re-growth during follow-up

  10 years

• Local recurrence after salvage surgery due to regrowth

  10 years

• Results after surgery for re-growth

  10 years

• Long-term survival

  10 years

• Number of patients with no response, partial response and complete response.

  Accrual period - probably 4 years

Study Arms (2)

No surgery

EXPERIMENTAL

Patients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to establish agreement regarding interpretation.

Procedure: endoscopy; Device: MRI

Surgery

ACTIVE COMPARATOR

Patients with indication of complete response on follow-up MRI will undergo endoscopy, and digital rectal examination to ascertain complete response. MRI together with documentation from endoscopy will be reviewed at the Regional University Hospital to establish agreement regarding interpretation. Patients with complete response will be offered watch and wait strategy, but the patients that want surgery will be operated according to the multi disciplinary conference decision.

Procedure: Surgery; Device: MRI

Interventions

endoscopy PROCEDURE

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

No surgery

Surgery PROCEDURE

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

Surgery

MRI DEVICE

No surgery; Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response

Interventions

Endoscopy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Eva Angenete, M.D., Ph.D.

  Sahlgrenska Academy at Gothenburg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Angenete, M.D., Ph.D.

CONTACT

eva.angenete@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D.

Model Details: All patients with complete response defined as described above will be offered to enter the study

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 24, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

SE (2)