No Surgery Trial / Two Dose-escalation Strategies

NCT ID: NCT03051464

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2030-01-31

Brief Summary

A randomized study of 131 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).

Detailed 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.

Conditions

Stage II Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemoradiation + EBRT Boost

standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders

Group Type: EXPERIMENTAL

Complete responders and Non-complete responders

Intervention Type: PROCEDURE

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Chemoradiation + EBRT Boost

Intervention Type: RADIATION

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

Chemoradiation + HDRBT Boost

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; Complete responders and Non-complete responders

Group Type: EXPERIMENTAL

Complete responders and Non-complete responders

Intervention Type: PROCEDURE

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Chemoradiation + HDRBT Boost

Intervention Type: RADIATION

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Interventions

Complete responders and Non-complete responders

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Intervention Type: PROCEDURE

Chemoradiation + EBRT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Te Vuong

Director, Radiation Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Te Vuong, MD

Role: PRINCIPAL_INVESTIGATOR

Sir Mortimer Jewish General Hospital

Locations

Hôpital Pierre Boucher

Longueuil, Quebec, Canada

Site Status: TERMINATED

Le Centre Hospitalier de l'Université de Montreal

Montreal, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Centre hospitalier universitaire de Québec

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stephan Bukera, BSc, MSc

Role: CONTACT

stephan.bukera.ccomtl@ssss.gouv.qc.ca

514-340-8222 ext. 26199

Facility Contacts

Nassima Taleb

Role: primary

nassima.taleb.chum@ssss.gouv.qc.ca

514-890-8000 ext. 10812

Stephan Bukera, BSc, MSc

Role: primary

stephan.bukera.ccomtl@ssss.gouv.qc.ca

514-340-8222 ext. 28443

André-Guy Martin, MD

Role: primary

Other Identifiers

16-301

Identifier Type: -

Identifier Source: org_study_id