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Colorectal CancerPhase 2NCT00114231

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

A Phase 2 study testing capecitabine, oxaliplatin and neoadjuvant therapy in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 67 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine, oxaliplatin and neoadjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
67 sitesUnited States
Study dates
May 2006to Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2
  • Patient must have histologically confirmed invasive adenocarcinoma of the rectum; Note: patients with rectal tumors suspicious for invasion also are eligible
  • Distal border of the patient's tumor must be within 8 cm from the anal verge as measured on endoscopic exam
  • Patients with tumors fixed to adjacent structures on digital exam are NOT eligible
  • Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4 tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm
  • Patients with positive perirectal nodes on ERUS examination are NOT eligible
  • Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are NOT eligible
  • Patients with the following conditions are NOT allowed on study:
  • Metastatic disease or other primaries (patient must have had chest X-ray/computed tomography [CT] and abdominal \& pelvic CT/MRI with IV contrast, as well as a colonoscopy)
  • Previously documented history of familial adenomatous polyposis
  • Previously documented history of hereditary non-polyposis colorectal cancer diagnosed clinically (Amsterdam II criteria) or by genetic testing
  • History of inflammatory bowel disease
  • History of prior radiation treatments to pelvis
  • Clinically significant peripheral sensory or motor neuropathy (defined as symptomatic weakness, paresthesia or sensory alteration described to be interfering with function, interfering with activities of daily living, disabling or life-threatening)
  • History of any clinically significant cardiac disease (i.e., class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the last 6 months)
  • History of uncontrolled seizures or clinically significant central nervous system disorders
  • History of psychiatric conditions or diminished mental capacity that could compromise the giving of informed consent, or interfere with study compliance
  • History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin
  • History of difficulty or inability to take or absorb oral medications
  • White blood cells (WBC) >= 3000/mm^3
  • Absolute neutrophil count (ANC) > 1,500/mm^3
  • Hemoglobin > 9.5 mg/dl
  • Platelet count >= 100,000/mm^3
  • Total bilirubin =< 3 mg/dl
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 times institutional upper limit of normal (ULN)
  • Alkaline phosphatase =< 2.0 times ULN
  • Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation
  • Patients who have experienced a prior malignancy must have received potentially curative therapy for that malignancy, and must be cancer-free for at least five years from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin carcinoma, or in-situ carcinomas)
  • Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • UPMC Cancer Center at Beaver Medical Center

    Beaver, Pennsylvania, 15009

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • UPMC Cancer Center at Jefferson Regional Medical Center

    Clairton, Pennsylvania, 15025

  • United Hospital Center

    Clarksburg, West Virginia, 26301

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • UPMC Cancer Center - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Methodist Hospital

    Houston, Texas, 77030

  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • UPMC Cancer Center at the John P. Murtha Pavilion

    Johnstown, Pennsylvania, 15901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • UPMC - Moon

    Moon Township, Pennsylvania, 15108

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • UPMC Cancer Center - Natrona Heights

    Natrona Heights, Pennsylvania, 15065

  • Jameson Memorial Hospital - North Campus

    New Castle, Pennsylvania, 16105

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Surgical Oncology Associates

    Newport News, Virginia, 23606

  • Integris Oncology Services

    Oklahoma City, Oklahoma, 73112

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC - Shadyside

    Pittsburgh, Pennsylvania, 15213-2582

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Center at UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • St. Clair Memorial Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Providence Cancer Center at Holy Family Hospital

    Spokane, Washington, 99207

  • Tampa General Hospital

    Tampa, Florida, 33606

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • John Muir/Mt. Diablo Comprehensive Cancer Center

    Walnut Creek, California, 94598

  • Washington Hospital Cancer Center

    Washington, Pennsylvania, 15301

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and radiotherapy followed by local excision.

Secondary

  • Determine the rate of resectability with negative resection margins in patients treated with this regimen.
  • Determine the procedure-specific morbidity and mortality in patients treated with this regimen.
  • Determine the rate of pathologic complete response of the primary tumor in patients treated with this regimen.
  • Determine the impact of this regimen on anorectal function and quality of life in these patients.
  • Determine the feasibility of using molecular studies to assess surgical resection margins and tumor response in patients treated with this regimen.
  • Determine molecular markers associated with local tumor recurrence in patients treated with this regimen.

OUTLINE: This is a non-randomized, multicenter study.

Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35 and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.

Quality of life is assessed at baseline and then 1 year after surgery.

After completion of study treatment, patients are followed at 1 month, every 4 months for 3 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.

Being tested
capecitabine, oxaliplatin, neoadjuvant therapy, radiation therapy
Keywords
adenocarcinoma of the rectum, stage I rectal cancer
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabineDrug

    Also called Given IV

  • oxaliplatinDrug

    Given IV

  • neoadjuvant therapyProcedure or surgery

    Also called therapeutic conventional surgery

    Undergo surgery

  • radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiotherapy

Study groups in NCT00114231
Study groupRoleWhat they receive
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)ExperimentalPatients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
Receives: Drug: capecitabine; Drug: oxaliplatin; Procedure: neoadjuvant therapy; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-Year Disease-free Survival

    The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.

    Measured: Up to 3 years

Secondary outcomes (4)

  1. R0 Resection Rate (Negative Margin Rate)

    The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.

    Measured: At time of surgery

  2. Morbidity and Mortality Rate

    Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.

    Measured: Up to 30 days

  3. Rate of Pathologic Complete Response of the Primary Tumor

    The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.

    Measured: Up to 5 years

  4. Local Recurrence Rate

    The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2005 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114231
Sponsor's protocol ID
ACOSOG-Z6041
Other IDs
ACOSOG-Z6041, U10CA180821, U10CA076001, CDR0000433145
Status last verified
Feb 2018
First submitted
13 Jun 2005
Last updated
29 Mar 2018
Data monitoring committee
Yes

Publications

  • Ota DM, Nelson H; ACOSOG Group Co-Chairs. Local excision of rectal cancer revisited: ACOSOG protocol Z6041. Ann Surg Oncol. 2007 Feb;14(2):271. doi: 10.1245/s10434-006-9213-7. Epub 2006 Nov 14. No abstract available.

    PubMed 17103255

  • Garcia-Aguilar J, Shi Q, Thomas CR Jr, Chan E, Cataldo P, Marcet J, Medich D, Pigazzi A, Oommen S, Posner MC. A phase II trial of neoadjuvant chemoradiation and local excision for T2N0 rectal cancer: preliminary results of the ACOSOG Z6041 trial. Ann Surg Oncol. 2012 Feb;19(2):384-91. doi: 10.1245/s10434-011-1933-7. Epub 2011 Jul 14.

    PubMed 21755378

  • Garcia-Aguilar J, Renfro LA, Chow OS, Shi Q, Carrero XW, Lynn PB, Thomas CR Jr, Chan E, Cataldo PA, Marcet JE, Medich DS, Johnson CS, Oommen SC, Wolff BG, Pigazzi A, McNevin SM, Pons RK, Bleday R. Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial. Lancet Oncol. 2015 Nov;16(15):1537-1546. doi: 10.1016/S1470-2045(15)00215-6. Epub 2015 Oct 22.

    PubMed 26474521

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine, oxaliplatin and neoadjuvant therapy in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-Year Disease-free Survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114231, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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