Oxaliplatin combined with infusional 5-fluorouracil and concomitant radiotherapy in inoperable and metastatic rectal cancer: a phase I trial
2005

Oxaliplatin and 5-FU with Radiotherapy for Rectal Cancer

Sample size: 16 publication Evidence: moderate

Author Information

Author(s): Loi S, Ngan S Y K, Hicks R J, Mukesh B, Mitchell P, Michael M, Zalcberg J, Leong T, Lim-Joon D, Mackay J, Rischin D

Primary Institution: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Hypothesis

Can oxaliplatin combined with infusional 5-fluorouracil and radiotherapy improve treatment outcomes in inoperable and metastatic rectal cancer?

Conclusion

The combination of oxaliplatin with infusional 5-FU and radiotherapy is feasible and well tolerated in patients with inoperable and metastatic rectal cancer.

Supporting Evidence

  • Oxaliplatin was well tolerated with manageable side effects.
  • 11 out of 12 primary tumors showed metabolic responses on FDG-PET imaging.
  • The recommended dose of oxaliplatin was determined to be 85 mg/m2.

Takeaway

This study tested a new treatment for patients with hard-to-treat rectal cancer, and it showed that the treatment is safe and can help patients feel better.

Methodology

A phase I dose escalation study was conducted to determine the recommended dose of oxaliplatin combined with 5-FU and radiotherapy in patients with inoperable or metastatic rectal cancer.

Limitations

The study had a small sample size and was limited to a phase I trial, which primarily focused on safety rather than efficacy.

Participant Demographics

12 males and 4 females, median age 65 years, with 94% having metastatic disease.

Statistical Information

Confidence Interval

95% CI for overall survival was 8 to >18 months.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602413

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