A phase I/II study of oxaliplatin when added to 5-fluorouracil and leucovorin and pelvic radiation in locally advanced rectal cancer: a Colorectal Clinical Oncology Group (CCOG) study
2005

Study on Oxaliplatin with Chemotherapy and Radiation for Rectal Cancer

Sample size: 32 publication Evidence: moderate

Author Information

Author(s): Sebag-Montefiore D, Glynne-Jones R, Falk S, Meadows H M, Maughan T

Primary Institution: Cancer Research UK

Hypothesis

What is the maximum tolerated dose of oxaliplatin when combined with 5-fluorouracil, leucovorin, and pelvic radiation in locally advanced rectal cancer?

Conclusion

The study found that the maximum tolerated dose of oxaliplatin is 150 mg/m², and the recommended dose is 130 mg/m², which shows promising results in treating locally advanced rectal cancer.

Supporting Evidence

  • The maximum tolerated dose of oxaliplatin was determined to be 150 mg/m².
  • 28 out of 32 patients completed all treatments as planned.
  • Histopathology showed a complete pathological response in 7% of cases.

Takeaway

Doctors tested a new medicine called oxaliplatin with other treatments to help people with a type of bowel cancer. They found a safe amount to use that helps shrink the tumors.

Methodology

This was a dose escalation study where patients received oxaliplatin in combination with chemotherapy and radiation, with the maximum tolerated dose being determined based on observed toxicities.

Limitations

The study had a small sample size and was limited to a specific patient population with locally advanced rectal cancer.

Participant Demographics

Median age was 60 years, with 24 males and 8 females.

Statistical Information

Confidence Interval

95% CI 43–77%

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602818

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