Colorectal CancerPhase 2NCT01622543
Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer
A Phase 2 study testing Folfox plus Bevacizumab and reolysin and Folfox plus Bevacizumab in people with Colorectal Cancer, run by Canadian Cancer Trials Group at 10 sites in Canada.
Trial summary
The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Folfox plus Bevacizumab and reolysin and Folfox plus Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 10 sitesCanada
- Study dates
- 26 Oct 2012to 12 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have a histological diagnosis of colorectal adenocarcinoma.
- All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies and must have provided informed consent for the release of the block.
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). All patients must have measurable disease as defined by RECIST 1.1.
- The criteria for defining measurable disease are as follows:
- Chest X-ray ≥ 20 mm CT/MRI scan (with slice thickness of < 5 mm) ≥ 10 mm longest diameter Physical exam (using calipers) ≥ 10 mm Lymph nodes by CT scan ≥ 15 mm measured in short axis
- Patients must have advanced and or metastatic disease, for which no curative therapy exists and for which systemic therapy is indicated.
Show all 27Show fewer
- ECOG performance of 0, 1 or 2.
- Age ≥ 18 years of age.
- Previous Therapy
- Surgery:
- Previous major surgery is permitted provided that it has been at least 21days prior to patient randomization and that wound healing has occurred.
- Chemotherapy:
- Patients may NOT have received any prior cytotoxic chemotherapy for advanced or metastatic disease. Prior adjuvant fluoropyrimidine-based therapy is permitted provided completed at least one year prior to enrollment and the regimen did not include oxaliplatin or bevacizumab. Exceptions may be made for low dose chemotherapy given as a radiosensitizing agent.
- Other Therapy:
- Patients may have received other therapies including immunotherapy, or with signal transduction inhibitors, providing that the patient has recovered from all reversible drug related toxicity (with the exception of alopecia) and adequate washout period has been met.
- Radiation:
- Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG.
- Laboratory Requirements (must be done within 7 days prior to randomization)
- Hematology:
- Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L
- Biochemistry:
- Serum creatinine ≤ 1.5 x ULN Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to conditions such as Gilbert's disease) ALT and AST ≤ 3 x ULN (Note: ≤ 5 x ULN if documented liver metastasis) Proteinuria < 2g/24 hrs (screen using spot testing; if ≥ grade 2 repeat with mid-stream urine - if still ≥ grade 2 then urine collection for 24 hours to confirm <2g/24hrs)
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
- Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life (EORTC QLQ-C30) in either English or French. The baseline assessment must already have been completed. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. The baseline assessment must be completed within 14 days prior to randomization.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.
Who cannot join
- Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for ≥ 3 years. (Please call NCIC CTG if any questions about the interpretation of this criterion).
- Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
- Patients with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection.
- Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
- Patients with history of central nervous system metastases or untreated spinal cord compression.
- Patients who have had prior treatment with oxaliplatin or bevacizumab, who have contraindications to treatment with 5FU (for e.g. known DPD deficiency or severe cardiac disease), and or neuropathy > grade 1.
- Patients who are not sterile unless they use an adequate method of birth control.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
London Regional Cancer Program
London, Ontario, N6A 4L6
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Randomized Phase II Study of Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients With Metastatic Colorectal Cancer.
The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.
Read the detailed description
Researchers doing this study also want to evaluate the side effects of reolysin when given together with FOLFOX6/ bevacizumab.
- Conditions
- Colorectal Cancer
- Being tested
- Folfox plus Bevacizumab and reolysin, Folfox plus Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folfox plus Bevacizumab and reolysinDrug
FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
Folfox plus BevacizumabDrug
FOLFOX6/bevacizumab given every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Folfox plus Bevacizumab and Reolysin | Active comparator | Not described Receives: Drug: Folfox plus Bevacizumab and reolysin |
| Folfox plus Bevacizumab | Active comparator | Not described Receives: Drug: Folfox plus Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 19 months
Secondary outcomes (3)
Changes in CEA Levels
Changes in CEA level from baseline to week 28 during treatment.
Measured: Baseline and at 28 weeks
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate =Proportion of (CR + PR) observed over all randomized patients.
Measured: 19 months
Overall Survival
Time from randomization to death from any cause or censored at the time of last known alive
Measured: From date of randomization to death from any cause or censored at the time of last known alive, assessed up to 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study start26 Oct 2012
- Primary completion18 Jan 2017
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Oncolytics Biotech
- Responsible party
- Sponsor
- Investigators
- Derek Jonker, Study chair, Ottawa Health Research Institute - General DivisionPatricia Tang, Study chair, Tom Baker Cancer Centre, Calgary, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622543
- Sponsor's protocol ID
- I210
- Status last verified
- Mar 2020
- First submitted
- 12 Jun 2012
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jonker DJ, Tang PA, Kennecke H, Welch SA, Cripps MC, Asmis T, Chalchal H, Tomiak A, Lim H, Ko YJ, Chen EX, Alcindor T, Goffin JR, Korpanty GJ, Feilotter H, Tsao MS, Theis A, Tu D, Seymour L. A Randomized Phase II Study of FOLFOX6/Bevacizumab With or Without Pelareorep in Patients With Metastatic Colorectal Cancer: IND.210, a Canadian Cancer Trials Group Trial. Clin Colorectal Cancer. 2018 Sep;17(3):231-239.e7. doi: 10.1016/j.clcc.2018.03.001. Epub 2018 Mar 8.
PubMed 29653857Provencher DM, Gallagher CJ, Parulekar WR, Ledermann JA, Armstrong DK, Brundage M, Gourley C, Romero I, Gonzalez-Martin A, Feeney M, Bessette P, Hall M, Weberpals JI, Hall G, Lau SK, Gauthier P, Fung-Kee-Fung M, Eisenhauer EA, Winch C, Tu D, MacKay HJ. OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer. Ann Oncol. 2018 Feb 1;29(2):431-438. doi: 10.1093/annonc/mdx754.
PubMed 29186319
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients With Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT01622543
- Acronym / sponsor ID
- I210
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Oncolytics Biotech
- Study start
- 26 Oct 2012 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.
Detailed description
Researchers doing this study also want to evaluate the side effects of reolysin when given together with FOLFOX6/ bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folfox plus Bevacizumab and Reolysin | Active comparator | Drug: Folfox plus Bevacizumab and reolysin |
| Folfox plus Bevacizumab | Active comparator | Drug: Folfox plus Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients must have a histological diagnosis of colorectal adenocarcinoma.
- All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies and must have provided informed consent for the release of the block.
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). All patients must have measurable disease as defined by RECIST 1.1.
- Chest X-ray ≥ 20 mm CT/MRI scan (with slice thickness of < 5 mm) ≥ 10 mm longest diameter Physical exam (using calipers) ≥ 10 mm Lymph nodes by CT scan ≥ 15 mm measured in short axis
- Patients must have advanced and or metastatic disease, for which no curative therapy exists and for which systemic therapy is indicated.
Key exclusion criteria (8 listed)
- Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for ≥ 3 years. (Please call NCIC CTG if any questions about the interpretation of this criterion).
- Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
- Patients with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection.
- Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
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 plus Bevacizumab and reolysinFOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter | Drug | Folfox plus Bevacizumab and Reolysin |
| Folfox plus BevacizumabFOLFOX6/bevacizumab given every 14 days. | Drug | Folfox plus Bevacizumab |
Primary outcome
Progression Free Survival
Time frame: 19 months
Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 secondary outcomes
Changes in CEA Levels
Time frame: Baseline and at 28 weeks
Objective Response Rate
Time frame: 19 months
Overall Survival
Time frame: From date of randomization to death from any cause or censored at the time of last known alive, assessed up to 49 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29653857Jonker DJ, Tang PA, Kennecke H, Welch SA, Cripps MC, Asmis T, Chalchal H, Tomiak A, Lim H, Ko YJ, Chen EX, Alcindor T, Goffin JR, Korpanty GJ, Feilotter H, Tsao MS, Theis A, Tu D, Seymour L. A Randomized Phase II Study of FOLFOX6/Bevacizumab With or Without Pelareorep in Patients With Metastatic Colorectal Cancer: IND.210, a Canadian Cancer Trials Group Trial. Clin Colorectal Cancer. 2018 Sep;17(3):231-239.e7. doi: 10.1016/j.clcc.2018.03.001. Epub 2018 Mar 8.
- Derived from this study: PubMed 29186319Provencher DM, Gallagher CJ, Parulekar WR, Ledermann JA, Armstrong DK, Brundage M, Gourley C, Romero I, Gonzalez-Martin A, Feeney M, Bessette P, Hall M, Weberpals JI, Hall G, Lau SK, Gauthier P, Fung-Kee-Fung M, Eisenhauer EA, Winch C, Tu D, MacKay HJ. OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer. Ann Oncol. 2018 Feb 1;29(2):431-438. doi: 10.1093/annonc/mdx754.
- 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. This study is not recruiting at the moment.
Derek Jonker study chair
Ottawa Health Research Institute - General Division
Patricia Tang study chair
Tom Baker Cancer Centre, Calgary, Canada
10 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 plus Bevacizumab and reolysin and Folfox plus Bevacizumab in people with Colorectal Cancer, run by Canadian Cancer Trials Group at 10 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 27 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622543, which also lists 2 linked publications.
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 23 Aug 2023.