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

This study has been completed.
Sponsor:
Information provided by:
Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier:
NCT00422864
First received: January 15, 2007
Last updated: December 14, 2011
Last verified: September 2011

January 15, 2007
December 14, 2011
October 2006
June 2009   (final data collection date for primary outcome measure)
Tolerability rate [ Time Frame: as per protocol ] [ Designated as safety issue: Yes ]
Tolerability rate
Complete list of historical versions of study NCT00422864 on ClinicalTrials.gov Archive Site
  • Toxicity rates [ Time Frame: as per protocol ] [ Designated as safety issue: Yes ]
  • Pelvic response rate [ Time Frame: as per protocol ] [ Designated as safety issue: No ]
  • Distant response rate [ Time Frame: as per protocol ] [ Designated as safety issue: No ]
  • Toxicity rates
  • Pelvic response rate
  • Distant response rate
Not Provided
Not Provided
 
A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer
A Single-Arm Prospective Trial Evaluating The Local And Systemic Benefits Of Oxaliplatin And 5FU With Concurrent Radiation In Patients With Metastatic Rectal Cancer

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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • Drug: 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.

  • Drug: 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.

  • Drug: 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.
  • Procedure: 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2011
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00422864
06/35
Not Provided
Sam Ngan, Peter MacCallum Cancer Centre
Peter MacCallum Cancer Centre, Australia
Not Provided
Principal Investigator: Sam Ngan Peter MacCallum Cancer Centre, Australia
Principal Investigator: Michael Michael Peter MacCallum Cancer Centre, Australia
Peter MacCallum Cancer Centre, Australia
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP