CompletedPhase 3ACTRN12609000662268

Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.

Short Course Oncology Therapy(SCOT). A study of post operative chemotherapy for 12 weeks versus 24 weeks with oxaliplatin/Fluorouracil (5FU) to establish disease free survival outcomes in locally advanced colon cancer.

Sponsor

Australasian Gastrointestinal Trials Group (AGITG)

Enrollment

213 participants

Start Date

Apr 20, 2010

Study Type

Interventional

Conditions

Colon Cancer

Summary

This study will evaluate the safety and efficacy of post-operative chemotherapy for 12 weeks versus 24 weeks in patients with locally advanced colon cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have stage III colon cancer which has been fully resected (i.e. removed by surgery). You should not have undergone any previous chemotherapy for your cancer. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo chemotherapy for 12 weeks. Participants in the other group will undergo chemotherapy for 24 weeks. Chemotherapy will either be with the drugs oxaliplatin/5-FU or oxaliplatin/capecitabine depending on the preference of your treating doctor. Participants will be regularly assessed for a period of up to 7 years to determine disease free survival, overall survival, toxicity, cost effectiveness and quality of life.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a shorter course of chemotherapy works as well as the standard longer course for people who have had surgery to remove stage III colon cancer. It is for adults aged 18 and over who had their cancer fully removed, have no remaining disease, and are in good overall health. People who have had previous chemotherapy or significant heart disease are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox). Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or foli

Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox). Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site. Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks.