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An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer

Phase 2
18 Years
Open (Enrolling)
Operable T2-3N+M0 Rectal Cancer (Stage III)

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Trial Information

An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer

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

Inclusion Criteria:

1. Pathology: Adenocarcinoma of the rectum.

2. T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria)

3. Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any
EMVI+ tumor

4. Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary
mould applicator (e.g. non obstructive tumor).

5. Tumour of less than 3.5 cm thickness documented at the CT Simulator.

6. Patient should be a suitable candidate for surgery and chemotherapy.

7. WHO performance status 0-2

8. Age > 18 years.

9. Written informed consent.

10. Adequate birth control measures in women with childbearing potential.

Exclusion Criteria:

1. Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral).

2. Evidence of distant metastases (M1).

3. Previous pelvic radiation.

4. Other cancers except for basal cell carcinoma of the skin or CIS of the cervix.

5. Presence of multiples small bowel loops trapped within the immediate tumor bed (post
hysterectomy or prostatectomy).

6. Extension of malignant disease to the anal canal

7. Patients with severe co-morbid conditions (recent MI, infections, AIDS, etc)

8. Pregnancy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles

Outcome Time Frame:

1 year post diagnosis

Safety Issue:


Principal Investigator

Te Vuong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sir Mortimer B. Davis - Jewish General Hospital


Canada: Health Canada

Study ID:

KIR 009



Start Date:

November 2009

Completion Date:

December 2020

Related Keywords:

  • Operable T2-3N+M0 Rectal Cancer (Stage III)
  • Rectal Neoplasms