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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00422864




Registration number
NCT00422864
Ethics application status
Date submitted
15/01/2007
Date registered
17/01/2007
Date last updated
15/12/2011

Titles & IDs
Public title
A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer
Scientific 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
Secondary ID [1] 0 0
06/35
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - oxaliplatin
Treatment: Drugs - fluorouracil
Treatment: Drugs - leucovorin
Treatment: Surgery - External beam radiotherapy

Treatment: Drugs: oxaliplatin
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.

Treatment: Drugs: fluorouracil
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.

Treatment: Drugs: leucovorin
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.

Treatment: Surgery: External beam radiotherapy
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tolerability rate
Timepoint [1] 0 0
as per protocol
Secondary outcome [1] 0 0
Toxicity rates
Timepoint [1] 0 0
as per protocol
Secondary outcome [2] 0 0
Pelvic response rate
Timepoint [2] 0 0
as per protocol
Secondary outcome [3] 0 0
Distant response rate
Timepoint [3] 0 0
as per protocol

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCaluum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00422864
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Ngan
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications