Combination Chemotherapy in Treating Patients With Resected Colon Cancer

NCT00378716 | Completed Phase 3 DMC

• 3 other identifiers: NSABP C-06U10CA012027NSABP-C-06
• Study Type: interventional
• Target: 1,608
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. PURPOSE: Randomized phase III trial to determine the effectiveness of uracil, tegafur,and leucovorin compared with fluorouracil plus leucovorin in patients with resected stage II or stage III colon cancer.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; stage III colon cancer; adenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

• Compare the relative efficacy of UFT + LV with that of 5-FU + LV in prolonging disease-free survival and survival

Secondary Outcomes (3)

• evaluate the prognostic significants of proposed biomarkers, alone or in combination, in patients treated with 5-FU + LV or UFT + LV

• Evaluate the relationships of various biomarkers to each other and to evaluate their association with patient and tumor characteristics

• Compare quality of life in patients with stage II and III carcinoma of the colon treated with either 5-FU + LV or UFT + LV regimen

Study Arms (2)

Group 1

ACTIVE COMPARATOR

5-FU + Leucovorin

Drug: 5-fluorouracil; Drug: leucovorin calcium

Group 2

EXPERIMENTAL

Uracil/Ftorarur + leucovorin

Drug: tegafur; Drug: uracil

Interventions

5-fluorouracil DRUG

Group 1

leucovorin calcium DRUG

Group 1

tegafur DRUG

Group 2

uracil DRUG

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon that has been curatively resected within 42 days prior to entry, as follows: Stage II (T3-4 N0 M0, Modified Astler-Coller B2/3), i.e., tumor invasion of the wall of the colon or extension into the pericolonic tissue Stage III (any T N1-3 M0), i.e., tumor invasion of any depth No sarcoma, lymphoma, or carcinoid histology No laparoscopically assisted colectomy unless performed on protocol NCCTG-934653 (intergroup study INT-0146) Entire tumor located above the peritoneal reflection on surgical exploration or more than 15 cm from anal verge on endoscopy Involved adjacent structures (e.g., bladder, small intestine, ovary) removed en bloc with histologically negative margins More than 1 synchronous primary colon tumor allowed Most advanced tumor used for stage assignment No previous or synchronous rectal cancer Intestinal obstruction allowed Preliminary or complementary colostomy allowed Walled-off perforation allowed No free perforation, i.e., free air or fluid in abdomen No prior invasive colon or rectal malignancy regardless of disease-free interval PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 10 years (excluding cancer diagnosis) Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST or ALT normal Renal: Creatinine normal Cardiovascular: No active ischemic heart disease No NYHA class III/IV status No myocardial infarction within 6 months No symptomatic arrhythmia within 6 months Other: No nonmalignant systemic disease that precludes protocol treatment No psychiatric or addictive disorder that precludes informed consent No second malignancy within 10 years except: Effectively treated nonmelanomatous skin cancer Surgically cured carcinoma in situ of the cervix Lobular carcinoma in situ of the breast No pregnant women Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy or radiotherapy

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

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Related Publications (9)

• Soran A, Nesbitt L, Mamounas EP, Lembersky B, Bryant J, Anderson S, Brown A, Passarello M. Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. Clin Trials. 2006;3(5):478-85. doi: 10.1177/1740774506070747.

  PMID: 17060221 BACKGROUND

• Wang SJ, Zamboni BA, Wieand HS, et al.: Conditional survival for patients with colon cancer: an analysis of National Surgical Adjuvant Breast and Bowel Project (NSABP) trials C-03 through C-06. [Abstract] J Clin Oncol 24 (Suppl 18): A-6005, 302s, 2006.

  BACKGROUND

• Wolmark N, Colangelo L, Wieand S. National Surgical Adjuvant Breast and Bowel Project trials in colon cancer. Semin Oncol. 2001 Feb;28(1 Suppl 1):9-13. doi: 10.1016/s0093-7754(01)90245-3.

  PMID: 11273592 BACKGROUND

• O'Connell MJ, Yothers G, Paik S, et al.: Relationship between tumor gene expression and recurrence in patients with stage II/III colon cancer treated with surgery + 5-FU/LV in NSABP C-06: consistency of results with two other independent studies. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-301, 2008.

  RESULT

• Kopec JA, Yothers G, Ganz PA, Land SR, Cecchini RS, Wieand HS, Lembersky BC, Wolmark N. Quality of life in operable colon cancer patients receiving oral compared with intravenous chemotherapy: results from National Surgical Adjuvant Breast and Bowel Project Trial C-06. J Clin Oncol. 2007 Feb 1;25(4):424-30. doi: 10.1200/JCO.2005.05.2597.

  PMID: 17264338 RESULT

• Lembersky BC, Wieand HS, Petrelli NJ, O'Connell MJ, Colangelo LH, Smith RE, Seay TE, Giguere JK, Marshall ME, Jacobs AD, Colman LK, Soran A, Yothers G, Wolmark N. Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol. 2006 May 1;24(13):2059-64. doi: 10.1200/JCO.2005.04.7498.

  PMID: 16648506 RESULT

• Soran A, Harlak A, Wilson JW, Nesbitt L, Lembersky BC, Wienad HS, O'Connell MJ. Diverticular disease in patients with colon cancer: subgroup analysis of national surgical adjuvant breast and bowel project protocol C-06. Clin Colorectal Cancer. 2006 Jul;6(2):140-5. doi: 10.3816/ccc.2006.n.031.

  PMID: 16945170 RESULT

• Wolmark N, Wieand S, Lembersky B, et al.: A phase III trial comparing oral UFT to FULV in stage II and III carcinoma of the colon: results of NSABP protocol C-06. [Abstract] J Clin Oncol 22 (Suppl 14): A-3508, 247s, 2004.

  RESULT

• Smith RE, Lembersky BC, Wieand HS, Colangelo L, Mamounas EP. UFT/leucovorin vs 5-FU/leucovorin in colon cancer. Oncology (Williston Park). 2000 Oct;14(10 Suppl 9):24-7.

  PMID: 11098486 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Fluorouracil; Leucovorin; Tegafur; Uracil

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)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Michael J. O'Connell, MD

  Allegheny Cancer Center at Allegheny General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: February 1, 1997
• Primary Completion: May 1, 2006
• Study Completion: April 1, 2009
• Last Updated: January 11, 2010

Record last verified: 2010-01