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

Primary Purpose

Rectal Cancer

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

oxaliplatin

fluorouracil

leucovorin

External beam radiotherapy

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Peter MacCaluum Cancer Centre

Outcomes

Primary Outcome Measures

Tolerability rate

Secondary Outcome Measures

Toxicity rates

Pelvic response rate

Distant response rate

Full Information

NCT ID

NCT00422864

First Posted

January 15, 2007

Last Updated

December 14, 2011

Sponsor

Peter MacCallum Cancer Centre, Australia

1. Study Identification

Unique Protocol Identification Number

NCT00422864

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Peter MacCallum Cancer Centre, Australia

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention 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). Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Description

Week 1: (after Oxaliplatin and leucovorin)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.

Intervention Type

Drug

Intervention Name(s)

leucovorin

Intervention 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) Week 6: as per Week 1, Weeks 11: as per Week 1.

Intervention Type

Procedure

Intervention Name(s)

External beam radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Tolerability rate

Time Frame

as per protocol

Secondary Outcome Measure Information:

Title

Toxicity rates

Time Frame

as per protocol

Title

Pelvic response rate

Time Frame

as per protocol

Title

Distant response rate

Time Frame

as per protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam Ngan

Organizational Affiliation

Peter MacCallum Cancer Centre, Australia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Michael

Organizational Affiliation

Peter MacCallum Cancer Centre, Australia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peter MacCaluum Cancer Centre

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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