Clinical trial NCT01274962: A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer
Official title: An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Operable T2-3N+M0 Rectal Cancer (Stage III)
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2011-01-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
timeFrame: 1 year post diagnosis
Secondary outcomes:
measure: Disease free survival rate (local recurrence and metastases)
timeFrame: 5 years post surgery
measure: Overall survival rate
timeFrame: 5 years post surgery
Other outcomes:
Locations:
city: Gatineau
country: Canada
facility: Hôpital de Gatineau
state: Quebec
city: Greenfield Park
country: Canada
facility: Hôpital Charles LeMoyne
state: Quebec
city: Longueuil
country: Canada
facility: Centre Hospitalier Pierre-Boucher
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: CHUM-Hôpital St-Luc
state: Quebec
city: Saint-Hyacinthe
country: Canada
facility: Hôpital Honoré-Mercier
state: Quebec
city: Salaberry-De-Valleyfield
country: Canada
facility: Hôpital du Suroît
state: Quebec
city: Québec
country: Canada
facility: CHUQ - Hôtel-Dieu de Québec
Study officials:
affiliation: Sir Mortimer B. Davis - Jewish General Hospital
name: Te Vuong, MD
role: PRINCIPAL_INVESTIGATOR
References: