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A Single-Arm Prospective Trial Evaluating The Local And Systemic Benefits Of Oxaliplatin And 5FU With Concurrent Radiation In Patients With Metastatic Rectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

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Trial Information

A Single-Arm Prospective Trial Evaluating The Local And Systemic Benefits Of Oxaliplatin And 5FU With Concurrent Radiation In Patients With Metastatic Rectal Cancer


- Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1
concurrent with oxaliplatin over 2 hrs, then 5-FU 400mg/m2 bolus Day 1, then 5-FU
continuous infusion 2.4 g/m2 over 46 hours from Day 1.

- Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2
oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of
radiotherapy,

- Week 6: as per Week 1,

- Weeks 8-10: as per Weeks 3-5

- Weeks 11: as per Week 1.


Inclusion Criteria:



1. Patients with previously untreated and pathologically proven
adenocarcinoma of the rectum with distant metastasis who would benefit from combined
local therapy and systemic chemotherapy.

2. Lower border of tumour must be within 15cm of anal verge.

3. Age >= 18 years.

4. ECOG Performance Status 0-2

5. Absolute Neutrophil Count > 1.5x10^9/L, haemoglobin > 100 g/L, and platelets >
100x10^9/L.

6. Renal: Creatinine clearance >= 55 mL/min (using radioisotope renal scan or derived
from serum creatinine using the Cockcroft-Gault formula).

7. Bilirubin <= 2.0 x upper limit of normal.

8. ALT <= 5 x upper limit of normal

9. Life expectancy in excess of 3 months.

10. No symptomatic peripheral neuropathy > grade 2.

11. Males or non-pregnant, non-lactating females. Female patients of child-bearing
potential, not surgically sterilized, must use an adequate form of contraception
(oral contraceptive pill or barrier method).

12. Signed informed consent

Exclusion Criteria:

1. Prior pelvic radiotherapy

2. Febrile intercurrent illness or infection.

3. History of myocardial infarction within the previous six months or unstable cardiac
disease or any other medical condition likely to compromise the safe delivery of
chemotherapy or radiotherapy.

4. Concurrent treatment with other anti-cancer therapy.

5. Significant medical conditions which in the opinion of the investigator would
compromise the planned delivery of the chemotherapy and radiotherapy or which may be
potentially exacerbated by these modalities.

6. Locally recurrent rectal cancer

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability rate

Outcome Time Frame:

as per protocol

Safety Issue:

Yes

Principal Investigator

Sam Ngan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Therapeutic Goods Administration

Study ID:

06/35

NCT ID:

NCT00422864

Start Date:

October 2006

Completion Date:

January 2011

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms

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