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CompletedNCT00096278Updated Jul 30, 2019Results posted

Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

A Phase 3 interventional study of Bevacizumab and Fluorouracil in Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7 and Stage IIB Colon Cancer AJCC v7, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,710
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To compare the relative efficacy of mFOLFOX6 + bevacizumab with that of mFOLFOX6 alone in prolonging disease-free survival (DFS).

SECONDARY OBJECTIVES:

I. To compare the relative efficacy of mFOLFOX6 + bevacizumab with that of mFOLFOX6 alone in prolonging survival (S).

TERTIARY OBJECTIVES:

I. To assess the persistence of proteinuria following the discontinuation of bevacizumab.

II. To correlate the development of proteinuria with clinical sequelae. III. To evaluate the risk factors for development of proteinuria. IV. To determine the effect of discontinuation of bevacizumab on hypertension. V. To estimate the incidence of delayed vascular events such as myocardia infarction, CNS ischemia, and thrombosis in patients receiving chemotherapy + bevacizumab.

VI. To assess the effect of bevacizumab on ovarian function in premenopausal women.

VII. To assess the incidence rate of immunogenicity and examine post-treatment serum levels of bevacizumab in patients receiving bevacizumab.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

02

Conditions studied

  • Colon Adenocarcinoma
  • Stage IIA Colon Cancer AJCC v7
  • Stage IIB Colon Cancer AJCC v7
  • Stage IIC Colon Cancer AJCC v7
  • Stage IIIA Colon Cancer AJCC v7
  • Stage IIIB Colon Cancer AJCC v7
  • Stage IIIC Colon Cancer AJCC v7

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03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 2,710 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must consent to be in the study and must have signed and dated an IRB approved consent form conforming to federal and institutional guidelines
  • Randomization must occur during the three-week interval beginning on postoperative day 29 and ending on postoperative day 50
  • The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if the patient is not a candidate for endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination
  • The patient must have had an en bloc complete gross resection of tumor (curative resection) by open laparotomy or laparoscopically-assisted colectomy; patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible

  • Patients must have histologically confirmed adenocarcinoma of the colon that meets one of the criteria below:

    • Stage II carcinoma (T3,4 N0 M0); the tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3); or directly invades other organs or structures, and/or perforates visceral peritoneum (T4)
    • Stage III carcinoma (any T N1,2 M0); the tumor has invaded to any depth, with involvement of regional lymph nodes

  • Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor are eligible if all of the following conditions are met:

    • All or a portion of the adjacent structure was removed en bloc with the primary tumor
    • In the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection")
    • Histologic evaluation by the pathologist confirms the margins of the resected specimen are not involved by malignant cells; and
    • Local radiation therapy will not be utilized
  • Patients with more than one synchronous primary colon tumor are eligible; (staging classification will be based on the more advanced primary tumor)
  • Patients must have an ECOG performance status of 0 or 1
  • At the time of randomization, postoperative absolute granulocyte count (AGC) must be >= 1500/mm\^3 (or \< 1500/mm\^3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal)
  • At the time of randomization, the postoperative platelet count must be >= 100,000/mm\^3
  • Bilirubin must be =\< ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
  • Alkaline phosphatase must be \< 2.5 x ULN for the lab

  • AST must be \< 1.5 x ULN for the lab

    • If AST is > ULN, serologic testing for hepatitis B and C must be performed and results must be negative
  • Serum creatinine =\< 1.5 x ULN for the lab
  • Urine protein/creatinine (UPC) ratio of \< 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate \< 1 gm of protein in the 24-hour urine collection in order to participate in the study
  • Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease-free for >= 5 years and are deemed by their physician to be at low risk for recurrence; patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 years old
  • Colon tumor other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, etc
  • Rectal tumors, i.e. a tumor located \< 12 cm from the anal verge on endoscopy, or by surgical exam if the patient is not a candidate for endoscopy
  • Isolated, distant, or non-contiguous intra-abdominal metastases, even if resected
  • Any systemic or radiation therapy initiated for this malignancy
  • Any significant bleeding that is not related to the primary colon tumor within 6 months before study entry
  • Serious or non-healing wound, skin ulcers, or bone fracture
  • Gastroduodenal ulcer(s) determined by endoscopy to be active

  • Invasive procedures defined as follows:

    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
    • Anticipation of need for major surgical procedures during the course of the study
    • Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization
  • Uncontrolled blood pressure defined as > 150/90 mmHg
  • History of TIA or CVA
  • History of arterial thrombotic event within 12 months before study entry
  • Symptomatic peripheral vascular disease

  • PT/INR > 1.5, unless the patient is on therapeutic doses of warfarin. If so, the following criteria must be met for enrollment:

    • The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin
    • The subject must not have active bleeding or a pathological condition that is associated with a high-risk of bleeding
  • Concomitant halogenated antiviral agents
  • Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI Common Terminology Criteria for Adverse Events Version 3.0 [CTCAE v3.0] as grade 2 or greater neurosensory or neuromotor toxicity)

  • Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs; specifically excluded are the following cardiac conditions:

    • New York Heart Association Class III or IV cardiac disease
    • History of myocardial infarction within 12 months before study entry
    • Unstable angina within 12 months before study entry; and
    • Symptomatic arrhythmia
  • History of chronic or persistent viral hepatitis or other chronic liver disease
  • Pregnancy or lactation at the time of proposed randomization; eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy and for at least 3 months after the completion of bevacizumab
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,710 participants (actual)

Study arms

  • Active comparator
    Arm I (mFOLFOX6)

    Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.

    Drug: Fluorouracil · Drug: Leucovorin Calcium · Drug: Oxaliplatin

  • Experimental
    Arm II (bevacizumab, mFOLFOX6)

    Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

    Biological: Bevacizumab · Drug: Fluorouracil · Drug: Leucovorin Calcium · Drug: Oxaliplatin

Interventions

  • BiologicalBevacizumab

    Given IV

    Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar SCT501, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501

  • DrugFluorouracil

    Given IV

    Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

  • DrugLeucovorin Calcium

    Given IV

    Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, citrovorum factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

  • DrugOxaliplatin

    Given IV

    Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

06

What researchers measure

Primary outcomes

  1. Disease-free Survival

    Where events are defined as recurrence, second primary cancer, or death from any cause

    Time frame: 3 years

Secondary outcomes

  1. Survival

    Percentage of patients who did not experience an event where events are defined as death from any cause.

    Time frame: 5 years

Other outcomes

  1. Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab

    Time frame: Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy

  2. Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test

    Time frame: Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization

  3. Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab

    Time frame: Events measured regularly during chemotherapy and bevacizumab therapy

  4. As Measured by Blood Pressure and Antihypertensive Medication Hypertension

    Time frame: Group 2, every 3 months for one year post treatment

  5. The Risk Factors for Development of Proteinuria

    Time frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

  6. Proteinuria With Clinical Sequelae

    Time frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

  7. Proteinuria After Completion of Bevacizumab

    Time frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

07

Results

Posted Dec 3, 2012

Participant flow

Participant flow — Overall Study
MilestoneArm 1: Oxaliplatin + Leucovorin + 5-FluorouracilArm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Started13561354
Completed13381334
Not completed1820
Withdrew: No follow-up data1518
Withdrew: Patient not at risk for primary endpoint32

Outcome measures

PrimaryDisease-free Survival

Where events are defined as recurrence, second primary cancer, or death from any cause

Time frame:
3 years
Reported as:
Number · percentage of patients
Disease-free Survival
percentage of patientsArm 1: Oxaliplatin + Leucovorin + 5-FluorouracilArm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Disease-free Survival75.577.4
SecondarySurvival

Percentage of patients who did not experience an event where events are defined as death from any cause.

Time frame:
5 years
Reported as:
Number · percentage of patients
Survival
percentage of patientsArm I (mFOLFOX6)Arm II (Bevacizumab, mFOLFOX6)
Survival77.678.7
Other pre-specifiedBevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab
Time frame:
Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy

No measurements were reported for this outcome.

Other pre-specifiedOvarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test
Time frame:
Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization

No measurements were reported for this outcome.

Other pre-specifiedDelayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab
Time frame:
Events measured regularly during chemotherapy and bevacizumab therapy

No measurements were reported for this outcome.

Other pre-specifiedAs Measured by Blood Pressure and Antihypertensive Medication Hypertension
Time frame:
Group 2, every 3 months for one year post treatment

No measurements were reported for this outcome.

Other pre-specifiedThe Risk Factors for Development of Proteinuria
Time frame:
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

Results for this outcome have not been posted.

Other pre-specifiedProteinuria With Clinical Sequelae
Time frame:
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

Results for this outcome have not been posted.

Other pre-specifiedProteinuria After Completion of Bevacizumab
Time frame:
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxaliplatin + Leucovorin + 5-Fluorouracil—81/1,326 (6.1%)954/1,326 (71.9%)
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab—270/1,334 (20.2%)1,043/1,334 (78.2%)
Most frequent serious events
Showing 10 of 179
Most frequent serious events
EventOxaliplatin + Leucovorin + 5-FluorouracilOxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Thromboembolic eventVascular disorders28/132647/1334
Vascular access complicationInjury, poisoning and procedural complications5/132625/1334
DehydrationMetabolism and nutrition disorders2/132622/1334
DiarrheaGastrointestinal disorders1/132620/1334
HypertensionVascular disorders0/132617/1334
VomitingGastrointestinal disorders1/132616/1334
Wound dehiscenceInjury, poisoning and procedural complications1/132616/1334
Abdominal painGastrointestinal disorders1/132615/1334
NauseaGastrointestinal disorders1/132614/1334
DyspneaRespiratory, thoracic and mediastinal disorders3/132613/1334
Most frequent other events
Most frequent other events
EventOxaliplatin + Leucovorin + 5-FluorouracilOxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Peripheral sensory neuropathyNervous system disorders586/1326660/1334
Neutrophil count decreasedInvestigations433/1326400/1334
HypertensionVascular disorders24/1326172/1334
DiarrheaGastrointestinal disorders128/1326153/1334
FatigueGeneral disorders98/1326122/1334
Thromboembolic eventVascular disorders64/132685/1334
White blood cell decreasedInvestigations73/132658/1334
DepressionPsychiatric disorders53/132670/1334
DehydrationMetabolism and nutrition disorders53/132667/1334

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oxaliplatin + Leucovorin + 5-FluorouracilOxaliplatin + Leucovorin + 5-Fluorouracil + BevacizumabTotal
Mean57 ± 11.656 ± 11.357 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)Oxaliplatin + Leucovorin + 5-FluorouracilOxaliplatin + Leucovorin + 5-Fluorouracil + BevacizumabTotal
Female6806781358
Male6766761352
08

Study locations

1 site
  • National Surgical Adjuvant Breast and Bowel Project
    Pittsburgh, Pennsylvania 15212-5234, United States
09

References and documents

Publications

  • Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23. PubMed 33356421 ↗
  • Penney KL, Banbury BL, Bien S, Harrison TA, Hua X, Phipps AI, Sun W, Song M, Joshi AD, Alberts SR, Allegra CJ, Atkins J, Colangelo LH, George TJ, Goldberg RM, Lucas PC, Nair SG, Shi Q, Sinicrope FA, Wolmark N, Yothers G, Peters U, Newcomb PA, Chan AT. Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer. Clin Gastroenterol Hepatol. 2020 Nov;18(12):2717-2723.e3. doi: 10.1016/j.cgh.2019.11.046. Epub 2019 Dec 4. PubMed 31811950 ↗
  • Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208. PubMed 31268130 ↗
  • Sinicrope FA, Shi Q, Allegra CJ, Smyrk TC, Thibodeau SN, Goldberg RM, Meyers JP, Pogue-Geile KL, Yothers G, Sargent DJ, Alberts SR. Association of DNA Mismatch Repair and Mutations in BRAF and KRAS With Survival After Recurrence in Stage III Colon Cancers : A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Oncol. 2017 Apr 1;3(4):472-480. doi: 10.1001/jamaoncol.2016.5469. PubMed 28006055 ↗
  • Allegra CJ, Yothers G, O'Connell MJ, Sharif S, Petrelli NJ, Lopa SH, Wolmark N. Bevacizumab in stage II-III colon cancer: 5-year update of the National Surgical Adjuvant Breast and Bowel Project C-08 trial. J Clin Oncol. 2013 Jan 20;31(3):359-64. doi: 10.1200/JCO.2012.44.4711. Epub 2012 Dec 10. PubMed 23233715 ↗
  • Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. doi: 10.1093/jnci/djr310. Epub 2011 Oct 12. PubMed 21997132 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00096278
Lead sponsor
National Cancer Institute (NCI)
Collaborators
NSABP Foundation Inc
Responsible party
Sponsor
First posted
Nov 9, 2004
Start date
Sep 15, 2004
Primary completion
Mar 12, 2009
Completion
Dec 31, 2012
Results posted
Dec 3, 2012
Last update
Jul 30, 2019

Study contacts

Carmen J Allegra
principal investigator · NSABP Foundation Inc
View the source record on ClinicalTrials.gov ↗

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