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

Active, not recruiting

• Conditions: Rectal cancer; Locally Advanced Rectal Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12608000403336
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1090

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival, defined as the time interval from randomisation to the first event of loco-regional failure, metastatic recurrence, the appearance of a secondary colorectal cancer or death.[During Treatment: 4-8 weeks after surgery and at the end of last cycle of chemotherapy; or as indicated if suspected progression. Follow-up: every 3 months for 3 years, then every 6 months for years 4-5, or as required if suspected progression.]