Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer

NCT00560365 | Unknown

• 4 other identifiers: CDR0000576476USCTU-FACSISRCTN41458548EU-20788
• Study Type: observational
• Target: 4,760
• Locations: 1 country
• Sites: 31

Brief Summary

RATIONALE: Following patients who have undergone surgery for colorectal cancer may help doctors learn more about the disease and plan better follow-up care. PURPOSE: This randomized clinical trial is following patients who have undergone surgery for stage I, stage II, or stage III colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage I colon cancer; stage II colon cancer; stage III colon cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival by intention-to-treat analysis

Secondary Outcomes (3)

• Quality of life

• Cost of National Health Service (NHS) services utilized

• NHS cost per life-year saved

Interventions

laboratory biomarker analysis OTHER

computed tomography PROCEDURE

magnetic resonance imaging PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of primary colorectal cancer * Stage I-III disease * Have undergone curative resection (i.e., no residual disease \[R0\]) * Microscopically clear margins * Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy * Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR \< 2 times upper limit of normal (if normal range is \> 5 ng/mL) * For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy * Has completed primary curative treatment, as deemed by hospital clinician * Patients awaiting stoma closure allowed * No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray) * No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer PATIENT CHARACTERISTICS: * No concurrent serious illness * History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved * No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (31)

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

RECRUITING

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

RECRUITING

Saint Richards Hospital

Chichester, England, P019 4SE, United Kingdom

RECRUITING

Queen Alexandra Hospital

Cosham, England, PO6 3LY, United Kingdom

RECRUITING

Castle Hill Hospital

Cottingham, England, HU16 5JQ, United Kingdom

RECRUITING

Mid Cheshire Hospitals Trust- Leighton Hopsital

Crewe, England, CW1 4QJ, United Kingdom

RECRUITING

Mayday University Hospital

Croydon, England, United Kingdom

RECRUITING

Darent Valley Hospital

Dartford Kent, England, DA2 8DA, United Kingdom

RECRUITING

Royal Derby Hospital

Derby, England, DE22 3NE, United Kingdom

RECRUITING

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

RECRUITING

Grantham and District Hospital

Grantham, Lincolnshire, England, NG31 8DG, United Kingdom

RECRUITING

Harrogate District Hospital

Harrogate, England, HG2 7SX, United Kingdom

RECRUITING

St. Mark's Hospital

Harrow, England, HA1 3UJ, United Kingdom

RECRUITING

Wycombe General Hospital

High Wycombe, England, United Kingdom

RECRUITING

Hinchingbrooke Hospital

Huntingdon, England, PE18 6NT, United Kingdom

RECRUITING

West Middlesex University Hospital

Isleworth, England, TW7 6AF, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

RECRUITING

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

RECRUITING

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

RECRUITING

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

RECRUITING

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

RECRUITING

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

RECRUITING

Solihull Hospital

Solihull, England, B91 2JL, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

St. Peter's Hospital

Surrey, England, KT 16 OPZ, United Kingdom

RECRUITING

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

RECRUITING

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

RECRUITING

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

RECRUITING

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• John N. Primrose, MD

  University Hospital Southampton NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: March 1, 2004
• Primary Completion: December 1, 2013
• Last Updated: August 8, 2011

Record last verified: 2009-08

Locations

GB (31)