Stage II Rectal CancerPhase 2/3MORPHEUSNCT03051464
Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
A Phase 2/3 study testing Complete responders and Non-complete responders, Chemoradiation + EBRT Boost and Chemoradiation + HDRBT Boost in people with Stage II Rectal Cancer and Organ Preservation, run by Sir Mortimer B. Davis - Jewish General Hospital at 4 sites in 2 countries.
Trial summary
A randomized study of 131 patients. 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment
- What is being tested?
- Complete responders and Non-complete responders, Chemoradiation + EBRT Boost and Chemoradiation + HDRBT Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Apr 2017to Jan 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
- Rectal cancer staged as N0-1 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Canada3 sites, 3 recruiting
- Recruiting
Le Centre Hospitalier de l'Université de Montreal
Montreal, Quebec, H2X0A9
Nassima Taleb, 514-890-8000 ext. 10812, nassima.taleb.chum@ssss.gouv.qc.ca
Carole Richard, MD
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Susanne Knoepfel, 514-340-8222 ext. 21285, sknoepfel@jgh.mcgill.ca
Te Vuong, MD
- Recruiting
Centre hospitalier universitaire de Québec
Québec, Quebec, G2L2Z3
André-Guy Martin, MD
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Cristian Gonzales, 214-645-5360, Cristian.Gonzalez@UTSouthwestern.edu
Aurelie Garant, MD
About this study
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
A randomized study of 131 patients. 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).
Read the 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, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients
- Being tested
- Complete responders and Non-complete responders, Chemoradiation + EBRT Boost, Chemoradiation + HDRBT Boost
- Keywords
- rectal cancer, non-operative management, rectal preservation, organ preservation, brachytherapy boost for rectal cancer, low rectal cancer curative treatment, mid rectal cancer curative treatment, rectal brachytherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete responders and Non-complete respondersProcedure or surgery
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
Chemoradiation + EBRT BoostRadiation
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
Chemoradiation + HDRBT BoostRadiation
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation + EBRT Boost | Experimental | 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 Receives: Procedure: Complete responders and Non-complete responders; Radiation: Chemoradiation + EBRT Boost |
| Chemoradiation + HDRBT Boost | Experimental | 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 Receives: Procedure: Complete responders and Non-complete responders; Radiation: Chemoradiation + HDRBT Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
TME-free survival
Time from date of randomization to either TME or death in the intention to treat population
Measured: 2 years post treatment
Secondary outcomes (4)
Local Recurrence
Number of participants with Local recurrence as assessed by tests during follow-up visits.
Measured: 2 years post treatment
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.
Measured: 5 years post treatment
Overall survival
The time between date of randomization and date of death due to any causes.
Measured: 5 years post treatment
Overall Quality of life
Quality of life Questionnaires over different time point
Measured: 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start25 Apr 2017
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Te Vuong, MD, Principal investigator, Sir Mortimer Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051464
- Sponsor's protocol ID
- 16-301
- Acronym
- MORPHEUS
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2017
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03051464
- Acronym / sponsor ID
- MORPHEUS / 16-301
- Conditions
- Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients
- Keywords
- rectal cancer, non-operative management, rectal preservation, organ preservation, brachytherapy boost for rectal cancer, low rectal cancer curative treatment, mid rectal cancer curative treatment, rectal brachytherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized study of 131 patients. 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation + EBRT Boost | Experimental | Procedure: Complete responders and Non-complete responders, Radiation: Chemoradiation + EBRT Booststandard 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 |
| Chemoradiation + HDRBT Boost | Experimental | Procedure: Complete responders and Non-complete responders, Radiation: Chemoradiation + HDRBT Booststandard 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
- Rectal cancer staged as N0-1 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete responders and Non-complete respondersPatients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery. | Procedure or surgery | Chemoradiation + EBRT Boost, Chemoradiation + HDRBT Boost |
| Chemoradiation + EBRT Boost45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5 | Radiation | Chemoradiation + EBRT Boost |
| Chemoradiation + HDRBT Boost45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions | Radiation | Chemoradiation + HDRBT Boost |
Primary outcome
TME-free survival
Time frame: 2 years post treatment
Time from date of randomization to either TME or death in the intention to treat population
4 secondary outcomes
Local Recurrence
Time frame: 2 years post treatment
Disease-free survival
Time frame: 5 years post treatment
Overall survival
Time frame: 5 years post treatment
Overall Quality of life
Time frame: 5 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Te Vuong, MD principal investigator
Sir Mortimer Jewish General Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Complete responders and Non-complete responders, Chemoradiation + EBRT Boost and Chemoradiation + HDRBT Boost in people with Stage II Rectal Cancer and Organ Preservation, run by Sir Mortimer B. Davis - Jewish General Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Knoepfel (5143408288 ext. 21285, sknoepfel@jgh.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TME-free survival (time frame: 2 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.