A Phase 2 interventional study of FOLFOX and high dose rate endorectal brachytherapy in Operable T2-3N+M0 Rectal Cancer (Stage III), sponsored by Sir Mortimer B. Davis - Jewish General Hospital. Completed at 8 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Sir Mortimer B. Davis - Jewish General Hospital · Phase 2, Interventional, and Treatment
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 180 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Sir Mortimer B. Davis - Jewish General Hospital is the lead sponsor of 61 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: FOLFOX · Radiation: high dose rate endorectal brachytherapy
Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery
Drug: FOLFOX · Radiation: high dose rate endorectal brachytherapy
* 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 brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.
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
Disease free survival rate (local recurrence and metastases)
Time frame: 5 years post surgery
Overall survival rate
Time frame: 5 years post surgery
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Sir Mortimer B. Davis - Jewish General Hospital