- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274962
A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer
An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Québec, Canada, G1R 2J6
- CHUQ - Hôtel-Dieu de Québec
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Quebec
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Gatineau, Quebec, Canada, J8T 8R2
- Hôpital de Gatineau
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hopital Charles LeMoyne
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Longueuil, Quebec, Canada, J4M 2A5
- Centre Hospitalier Pierre-Boucher
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Montreal, Quebec, Canada, H3T 1E2
- Sir Mortimer B. Davis - Jewish General Hospital
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Montréal, Quebec, Canada, H2X 3J4
- CHUM-Hôpital St-Luc
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Saint-Hyacinthe, Quebec, Canada, J2S 4Y8
- Hôpital Honoré-Mercier
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Salaberry-De-Valleyfield, Quebec, Canada, J6T 6C1
- Hôpital du Suroît
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- WHO performance status 0-2
- Age > 18 years.
- Written informed consent.
- Adequate birth control measures in women with childbearing potential.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A - neoadjuvant chemotherapy
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
|
If necessary the schedule may be modified +/- 3 days.
High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.
|
Experimental: Arm B - adjuvant chemotherapy
Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery
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If necessary the schedule may be modified +/- 3 days.
High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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1 year post diagnosis
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival rate (local recurrence and metastases)
Time Frame: 5 years post surgery
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5 years post surgery
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Overall survival rate
Time Frame: 5 years post surgery
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5 years post surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Te Vuong, MD, Sir Mortimer B. Davis - Jewish General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIR 009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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