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

Inclusion Criteria12

Patients may be included in the trial only if they meet all of the following criteria
Previously untreated and pathologically proven adenocarcinoma of the rectum.
MRI staged T3 or T4, any N.
Lower border of tumour must be within 12 cm of anal verge.
Age = or > 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Absolute neutrophil count > 1.5×109/L, haemoglobin > 90 g/L, and platelets > 100×109/L.
Adequate renal function: Glomerular Filtration Rate (GFR) > 55mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
Bilirubin and Alanine aminotransferase (ALT) < or = 1.5 x upper limit of normal.
No symptomatic peripheral neuropathy > grade 2.
Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
Has provided written informed consent for participation in this trial

Exclusion Criteria11

Patients who fulfill any of the following criteria are not eligible for admission to the trial:
Presence of metastatic disease.
Prior pelvic radiotherapy
Febrile intercurrent illness or infection.
Previous history of unstable angina
Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
Acute coronary syndrome even if controlled with medication
Myocardial infarction within the last 12 months
Concurrent treatment with other anti-cancer therapy.
Significant medical condition 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.
Locally recurrent rectal cancer.

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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.