Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer

Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone to establish disease-free survival outcomes in locally advanced rectal cancer (PETACC-6)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000403336

Acronym

PETACC-6

Enrollment

1090

Registered

2008-08-18

Start date

2009-05-27

Completion date

2011-09-09

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will be used to investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in locally advanced rectal cancer.

Interventions

Radiotherapy: 0.8 Gy per fraction given every week day for 5 weeks, total of 45 Gy in 25 fractions. Capecitabine: (oral tablets) 1650mg/m2 daily on day 1-33 pre-operatively and 2000mg/m2 daily from day 1 to day 15 for 6 21-day cycles post-operatively AND Oxaliplatin: (intravenously) 50mg/m2 on days 1, 8, 15, 22, and 29 pre-operatively and 130mg/m2 on day 1 for 6 21-day cycles post-operatively.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1.Male or female patients with histologically proven adenocarcinoma of the rectum (tumour = 12 cm from the anal verge as assessed by rigid proctoscopy) 2.T3/4 or any node-positive disease 3.No evidence of metastatic disease 4.The disease must be considered either resectable at the time of entry or expected to become resectable after preoperative chemoradiation. 5.Age = 18 years. 6.World Health Organisation (WHO) / Eastern Cooperative Oncology Group (ECOG) Performance Status = 2 7.No prior cytotoxic chemotherapy or radiotherapy for rectal cancer. 8.No prior radiotherapy of the pelvis, for any reason. 9.Presence of adequate contraception in fertile patients. Pregnant or breastfeeding women are excluded from participation. 10.Adequate bone marrow, hepatic and renal function: 11.Haemoglobin = 10.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, 12. Alanine transaminase (ALAT)and aspartate transaminase (ASAT) = 2.5 x ULN 13.Alkaline phosphatase = 2.5 x ULN 14.Total bilirubin = 1.5 x ULN 15.Creatinine clearance > 50 mL/min 16.Creatinine = 1.5 x ULN 17.Ability to swallow tablets 18.Written informed consent

Exclusion criteria

1. Pregnant or breastfeeding women or fertile patients not using adequate contraception. 2.Prior cytotoxic chemotherapy or radiotherapy for rectal cancer. 3.Prior radiotherapy of the pelvis, for any reason. 4. Previous (within the last 5 years) or concurrent malignancies. 5.Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months. 6.Significant impairment of intestinal resorption (e.g. chronic diarrhoea, inflammatory bowel disease). 7.Pre-existing condition which would deter chemoradiotherapy or radiotherapy, i.e. fistulas, severe ulcerative colitis (particularly patients currently taking Sulphasalazine), Crohn’s disease, prior adhesions. 8.Peripheral neuropathy = grade 2 (according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0). 9.History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.

Outcome results