A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer

Sponsor

Peter MacCallum Cancer Centre, Australia (Other)

Overall Status

Completed

CT.gov ID

NCT00422864

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate, and (2) to determine toxicity rates, pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy (oxaliplatin/5-fluorouracil [5FU]) and radiotherapy regimen.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Drug: oxaliplatin Drug: fluorouracil Drug: leucovorin Procedure: External beam radiotherapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

Tolerability rate [as per protocol]

Secondary Outcome Measures

Toxicity rates [as per protocol]
Pelvic response rate [as per protocol]
Distant response rate [as per protocol]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy.
Lower border of tumour must be within 15cm of anal verge.
Age >= 18 years.
ECOG Performance Status 0-2
Absolute Neutrophil Count > 1.5x10^{9/L, haemoglobin > 100 g/L, and platelets >
100x10}9/L.
Renal: Creatinine clearance >= 55 mL/min (using radioisotope renal scan or derived from serum creatinine using the Cockcroft-Gault formula).
Bilirubin <= 2.0 x upper limit of normal.
ALT <= 5 x upper limit of normal
Life expectancy in excess of 3 months.
No symptomatic peripheral neuropathy > grade 2.
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).
Signed informed consent

Exclusion Criteria:

Prior pelvic radiotherapy
Febrile intercurrent illness or infection.
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.
Concurrent treatment with other anti-cancer therapy.
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.
Locally recurrent rectal cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peter MacCaluum Cancer Centre	Melbourne	Victoria	Australia	3002

Sponsors and Collaborators

Peter MacCallum Cancer Centre, Australia

Investigators

Principal Investigator: Sam Ngan, Peter MacCallum Cancer Centre, Australia
Principal Investigator: Michael Michael, Peter MacCallum Cancer Centre, Australia