CompletedPhase 2ACTRN12610000175077

Preoperative Radiotherapy and Chemotherapy in patients with locally advanced rectal cancer

Trans Tasman Radiation Oncology Group (TROG) 09.01 - A Phase II Trial to assess the tolerability of Integrated Preoperative Radiotherapy and Chemotherapy with Oxaliplatin 5-Flurouracil (5-FU) and Folinic Acid in Patients with Locally Advanced Rectal Cancer

Sponsor

Trans Tasman Radiation Oncology Group (TROG)

Enrollment

40 participants

Start Date

Apr 9, 2010

Study Type

Interventional

Conditions

Locally Advanced Rectal Cancer

Summary

This study looks at the effectiveness and tolerability of integrated radiotherapy and chemotherapy with oxaliplatin 5-flurouracil (5-fu) and folinic acid before surgery in patients with locally advanced adenocarcinoma of the rectum (back passage). Who is it for? You can join this study if you have locally advanced cancer of the rectum (back passage) which you have not yet received treatment for. Trial details Participants will receive integrated preoperative radiotherapy with FOLFOX chemotherapy over 11 weeks, prior to standard surgery 4-6 weeks later . Patients will be monitored to determine their tolerance and response to treatment.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a combination of radiation therapy and chemotherapy given before surgery for patients with locally advanced rectal cancer. It is for adults aged 18 and older with previously untreated rectal cancer (adenocarcinoma) that has grown into or through the bowel wall, with the tumor within 12cm of the anal opening.

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

Arm 1: Experimental - Integrated Preoperative Radiotherapy and chemotherapy. Treatment: Other - Radiation Therapy. Weeks 3-5: radiotherapy 25.2Gy in 14 fractions over 3 weeks. Weeks 8-10: radiot

Arm 1: Experimental - Integrated Preoperative Radiotherapy and chemotherapy. Treatment: Other - Radiation Therapy. Weeks 3-5: radiotherapy 25.2Gy in 14 fractions over 3 weeks. Weeks 8-10: radiotherapy 25.2Gy in 14 fractions over 3 weeks. Treatment: drugs - Oxaliplatin. Week 1, Day 1: Administered 1st - Oxaliplatin 100mg/m2 (over 2 hours), leucovorin 200 mg/m2 day 1 concurrent with oxaliplatin over 2 hrs, given intravenously. Weeks 6 and 11 are the same as week 1. Weeks 3-5: 85 mg/m2 Oxaliplatin, given intravenously, on first day of week 3. Weeks 8-10 are the same as weeks 3-5. Treatment: drugs - Flurouracil. Week 1, Day 1: Administered 2nd - 5-FU 400mg/m2 bolus, given intravenously. Week 1 Day 1: Administered 3rd - 5-FU continuous infusion 2.4 g/m2, given intravenously, over 46 hours from Day 1. Weeks 6 and 11 are the same as week 1. Weeks 3-5: Continuous 5-FU 200mg/m2/day, given intravenously, on days of radiotherapy. Weeks 8-10 are the same as weeks 3-5. Treatment: drug - Leucovorin. Week 1, Day 1: leucovorin 200mg/m2, given intravenously, Day 1 delivered concurrently with Oxaliplatin over 2 hours. Weeks 6 and 11 are the same as week 1. Treatment: Surgery - Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.