No Surgery Trial / Two Dose-escalation Strategies

Stage II Rectal Cancer Clinical Trial

— Morpheus  

Official title:

A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03051464
• Other study ID #: 16-301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 25, 2017
• Est. completion date: January 2030

Study information

• Verified date: March 2024
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Emma Starr, BHSc
• Phone: 514-340-8222
• Email: emma.starr.ccomtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized study of 145 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Description:

It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. After interim analysis on 40 patients of the pilot study a phase III study is proposed. We are therefore proposing a phase III multicentric study of 145 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical response. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: January 2030
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
• Rectal cancer staged as N0 by MRI or EUS/TRUS
• No metastatic lesion
• Rectal tumor occupying less than half of the circumference
• Tumor less than 5 cm on its largest dimension
• Tumor located at less than 10 cm from the anal verge
• Tumor penetration less than 5 mm in the mesorectal fat
• Tumor accessible for brachytherapy
• Lumen accessible for colonoscopy
• Patient should be a suitable candidate for brachytherapy and chemotherapy
• Older than 18 years of age
• Adequate birth control measures in women of childbearing potential
• Written informed consent

Exclusion Criteria:

• Patients with previous pelvic radiation
• Evidence of distant metastasis
• Extension of malignant disease to the anal canal
• Tumors staged as T4
• Tumors larger than 5 cm in length

Related Conditions & MeSH terms

• Rectal Neoplasms
• Stage II Rectal Cancer

Intervention

Procedure:
• Complete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Radiation:
• Chemoradiation + EBRT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
• Chemoradiation + HDRBT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TME-free survival	Time from date of randomization to either TME or death in the intention to treat population	2 years post treatment
Secondary	Local Recurrence	Number of participants with Local recurrence as assessed by tests during follow-up visits.	2 years post treatment
Secondary	Disease-free survival	The time between the date of randomization and recurrence, either in the pelvis or metastases. Patients without an event will be censored at the last date the patient was known to be disease-free.	5 years post treatment
Secondary	Overall survival	The time between date of randomization and date of death due to any causes.	5 years post treatment
Secondary	Overall Quality of life	Quality of life Questionnaires over different time point	5 years post treatment