Operable T2-3N+M0 Rectal Cancer (Stage III)Phase 2NCT01274962
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer
A Phase 2 study testing FOLFOX and high dose rate endorectal brachytherapy in people with Operable T2-3N+M0 Rectal Cancer (Stage III), run by Sir Mortimer B. Davis - Jewish General Hospital at 8 sites in Canada.
Trial summary
This study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Operable T2-3N+M0 Rectal Cancer (Stage III)
- What is being tested?
- FOLFOX and high dose rate endorectal brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesCanada
- Study dates
- Nov 2009to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology: Adenocarcinoma of the rectum.
- T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria)
- Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any EMVI+ tumor
- Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary mould applicator (e.g. non obstructive tumor).
- Tumour of less than 3.5 cm thickness documented at the CT Simulator.
- Patient should be a suitable candidate for surgery and chemotherapy.
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- WHO performance status 0-2
- Age > 18 years.
- Written informed consent.
- Adequate birth control measures in women with childbearing potential.
Who cannot join
- Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral).
- Evidence of distant metastases (M1).
- Previous pelvic radiation.
- Other cancers except for basal cell carcinoma of the skin or CIS of the cervix.
- Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
- Extension of malignant disease to the anal canal
- Patients with severe co-morbid conditions (recent MI, infections, AIDS, etc)
- Pregnancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Hôpital de Gatineau
Gatineau, Quebec, J8T 8R2
Hôpital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1
Centre Hospitalier Pierre-Boucher
Longueuil, Quebec, J4M 2A5
CHUM-Hôpital St-Luc
Montreal, Quebec, H2X 3J4
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
CHUQ - Hôtel-Dieu de Québec
Québec, G1R 2J6
Hôpital Honoré-Mercier
Saint-Hyacinthe, Quebec, J2S 4Y8
Hôpital du Suroît
Salaberry-de-Valleyfield, Quebec, J6T 6C1
About this study
Official title: An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
This study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.
Read the detailed description
In recent randomized studies with preoperative combined chemotherapy and external beam radiation (EBRT/CT) with total mesorectal excision (TME surgery), the compliance to adjuvant chemotherapy ranged from 42.9% to 70%. This low compliance rate could influence the efficacy of chemotherapy. This is quite unique to patients with rectal cancer, since compliance is not a major issue in patients with colon cancer, belonging to the same age group. Therefore, it is reasonable to postulate that this difference might due to the additive toxicity burden of neoadjuvant EBRT/CT and TME.
In this randomized phase II study, compliance to chemotherapy will be compared in the two groups: In the first group, patients will receive half of their chemotherapy regimen in neoadjuvant and half in adjuvant; and, in the second group, patients will be receiving all their chemotherapy in adjuvant. Furthermore, brachytherapy will be used to deliver radiotherapy.
- Being tested
- FOLFOX, high dose rate endorectal brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXDrug
- Oxaliplatin* 85 mg/m2 IV in 500 mL of D5W over 120 minutes
- Folinic Acid (Leucovorin)* 400 mg/m2 IV in 250 ml D5W over 120 minutes
- 5-Fluorouracil (5-FU) 400 mg/m2 IV bolus, after Folinic Acid
- 5-Fluorouracil** 2400 mg/m2 IV over 46 h in D5W to a total volume of 92 mL by continuous infusion at 2 mL/hour.
- Repeat every 14 days for 6 cycles in the arm A and to be completed with 6 cycles after surgery and 12 cycles in arm B.
If necessary the schedule may be modified +/- 3 days.
high dose rate endorectal brachytherapyRadiation
High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.
| Study group | Role | What they receive |
|---|---|---|
| A - neoadjuvant chemotherapy | Experimental | Patients in arm A will receive 6 cycles of FOLFOX chemotherapy prior to radiotherapy and surgery as well as 6 cycles of chemotherapy in adjuvant Receives: Drug: FOLFOX; Radiation: high dose rate endorectal brachytherapy |
| Arm B - adjuvant chemotherapy | Experimental | Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery Receives: Drug: FOLFOX; Radiation: high dose rate endorectal brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
Measured: 1 year post diagnosis
Secondary outcomes (2)
Disease free survival rate (local recurrence and metastases)
Measured: 5 years post surgery
Overall survival rate
Measured: 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operable T2-3N+M0 Rectal Cancer (Stage III)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Te Vuong, MD, Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274962
- Sponsor's protocol ID
- KIR 009
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2011
- Last updated
- 26 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
- ClinicalTrials.gov ID
- NCT01274962
- Acronym / sponsor ID
- KIR 009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2009 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 12 Jan 2011 (estimated)
- 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.
This study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.
Detailed description
In recent randomized studies with preoperative combined chemotherapy and external beam radiation (EBRT/CT) with total mesorectal excision (TME surgery), the compliance to adjuvant chemotherapy ranged from 42.9% to 70%. This low compliance rate could influence the efficacy of chemotherapy. This is quite unique to patients with rectal cancer, since compliance is not a major issue in patients with colon cancer, belonging to the same age group. Therefore, it is reasonable to postulate that this difference might due to the additive toxicity burden of neoadjuvant EBRT/CT and TME.
In this randomized phase II study, compliance to chemotherapy will be compared in the two groups: In the first group, patients will receive half of their chemotherapy regimen in neoadjuvant and half in adjuvant; and, in the second group, patients will be receiving all their chemotherapy in adjuvant. Furthermore, brachytherapy will be used to deliver radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - neoadjuvant chemotherapy | Experimental | Drug: FOLFOX, Radiation: high dose rate endorectal brachytherapyPatients in arm A will receive 6 cycles of FOLFOX chemotherapy prior to radiotherapy and surgery as well as 6 cycles of chemotherapy in adjuvant |
| Arm B - adjuvant chemotherapy | Experimental | Drug: FOLFOX, Radiation: high dose rate endorectal brachytherapyPatients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathology: Adenocarcinoma of the rectum.
- T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria)
- Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any EMVI+ tumor
- Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary mould applicator (e.g. non obstructive tumor).
- Tumour of less than 3.5 cm thickness documented at the CT Simulator.
Key exclusion criteria (8 listed)
- Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral).
- Evidence of distant metastases (M1).
- Previous pelvic radiation.
- Other cancers except for basal cell carcinoma of the skin or CIS of the cervix.
- Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
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 |
|---|---|---|
| FOLFOX* Oxaliplatin* 85 mg/m2 IV in 500 mL of D5W over 120 minutes * Folinic Acid (Leucovorin)* 400 mg/m2 IV in 250 ml D5W over 120 minutes * 5-Fluorouracil (5-FU) 400 mg/m2 IV bolus, after Folinic Acid * 5-Fluorouracil** 2400 mg/m2 IV over 46 h in D5W to a total volume of 92 mL by continuous infusion at 2 mL/hour. * Repeat every 14 days for 6 cycles in the arm A and to be completed with 6 cycles after surgery and 12 cycles in arm B. If necessary the schedule may be modified +/- 3 days. | Drug | A - neoadjuvant chemotherapy, Arm B - adjuvant chemotherapy |
| high dose rate endorectal brachytherapyHigh dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy. | Radiation | A - neoadjuvant chemotherapy, Arm B - adjuvant chemotherapy |
Primary outcome
Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
Time frame: 1 year post diagnosis
2 secondary outcomes
Disease free survival rate (local recurrence and metastases)
Time frame: 5 years post surgery
Overall survival rate
Time frame: 5 years post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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. This study is not recruiting at the moment.
Te Vuong, MD principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX and high dose rate endorectal brachytherapy in people with Operable T2-3N+M0 Rectal Cancer (Stage III), run by Sir Mortimer B. Davis - Jewish General Hospital at 8 sites in Canada.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles (time frame: 1 year post diagnosis). 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 26 Jun 2024.