Prospective Randomised Trial Of Extended Chemotherapy During The Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer

Phase 3

Recruiting

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

• Registration Number: ACTRN12611000339954
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms. from the anal verge on rigid sigmoidoscopy)
2.Non-metastatic (M0) disease as evidenced by CT chest and abdomen
3. Patients who following MDT discussion, are deemed to require long course preoperative chemoradiotherapy as appropriate neo-adjuvant therapy for their rectal cancer prior to surgical management (clinical stage T3/4 or any node positive disease). The nature of surgical management will be at the discretion of the surgeon responsible for their care.
4.WHO/ECOG Performance status <= 2
5.Adequate bone marrow, hepatic, and renal fuction Haemoglobin greater than or equal to10.0 g/dL (transfusions allowed to achieve or maintain levels) absolute neutrophil count greater than or equal to 1.5 x 10 9/L
platelet count greater than or equal to 100 x 10 9/L
ALAT greater than or equal to10 2.5 x ULN
ASAT greater than or equal to10 2.5 x ULN
Alkaline phosphatase greater than or equal to10 2.5 x ULN
Total bilirubin greater than or equal to10 1.5 x ULN
Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
6.Presence of adequate contraception in fertile patients

Exclusion Criteria

Age – less than 18 or greater than 80 years
2. Inability to provide informed consent
3. Significant co-morbidities precluding the use of preoperative chemoradiotherapy, including the presence of clinically significant (i.e. active) cardiac disease
4. Known dihydropyrimidine dehydrogenase deficiency
5. Pregnant or breast feeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified