AzTrials
AzTrials

Colorectal CancerPhase 2NCT00613080

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

A Phase 2 study testing capecitabine, oxaliplatin and resection in people with Colorectal Cancer, run by Radiation Therapy Oncology Group at 120 sites in 2 countries.

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 work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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 resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
120 sitesin 2 countries
Study dates
Apr 2008to Dec 2016
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

Who may be able to join

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
  • Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
Show all 12Show fewer
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine clearance > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years

Who cannot join

  • Severe, active comorbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Show all 17Show fewer
  • AIDS
  • Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
  • Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
  • Evidence of peripheral neuropathy ≥ grade 2
  • Prior allergic reaction to oxaliplatin or capecitabine
  • Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
  • Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection)
  • Participation in any investigational drug study within 28 days of study enrollment.
  • Concurrent cimetidine, amifostine, and/or depot Sandostatin

Trial locations and contacts

120 sites in 2 countries.

120 sites in 2 countries

United States119 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • American Fork Hospital

    American Fork, Utah, 84003

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Maimonides Cancer Center at Maimonides Medical Center

    Brooklyn, New York, 11219

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

    City of Saint Peters, Missouri, 63376

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

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

    Hershey, Pennsylvania, 17033-0850

  • St. Vincent Oncology Center

    Indianapolis, Indiana, 46260

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Monter Cancer Center of the North Shore-LIJ Health System

    Lake Success, New York, 11042

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Riddle Memorial Hospital Cancer Center

    Media, Pennsylvania, 19063

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Upper Delaware Valley Cancer Center

    Milford, Pennsylvania, 18337

  • Columbia-Saint Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Integris Oncology Services

    Oklahoma City, Oklahoma, 73112

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Bay Medical

    Panama City, Florida, 32401

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Frankford Hospital Cancer Center - Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Mercy General Hospital

    Sacramento, California, 95819

  • Norris Cotton Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • LDS Hospital

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

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

    Savannah, Georgia, 31403-3089

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Precision Radiotherapy at University Pointe

    West Chester, Ohio, 45069

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • CCOP - Main Line Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada1 site

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

Other trials in Canada

About this study

Official title: A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity (grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with conventionally delivered radiotherapy, as was utilized in the capecitabine and oxaliplatin arm of RTOG-0247 (NCT00081289).

Secondary

  • To evaluate the feasibility of performing IMRT in a cooperative group setting for the treatment of rectal cancer.
  • To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment in the neoadjuvant period, the adjuvant period, and overall.
  • To estimate the pathologic complete response rate following neoadjuvant IMRT-based chemoradiotherapy.
  • To estimate the time to treatment failure and patterns of failure.
  • To correlate pre- and post-treatment levels of serum cytokines with symptoms during and pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer.
  • To evaluate the rate of abdominoperineal resections.

OUTLINE: This is a multicenter study.

  • Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy). Beginning on the first day of radiotherapy and continuing through completion of radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5 weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29.
  • Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo resection of the rectal tumor.
  • Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely resected disease and negative surgical margins receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.

Being tested
capecitabine, oxaliplatin, resection, radiation therapy, FOLFOX
Keywords
stage III rectal cancer, adenocarcinoma of the rectum
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

    1650 mg/m^2/day orally 5 days/week during radiotherapy.

  • oxaliplatinDrug

    Also called 50 mg/m^2 IV over 2 hours weekly for five weeks starting on day 1 of radiotherapy.

  • resectionProcedure or surgery

    All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.

  • radiation therapyRadiation

    Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx

  • FOLFOXDrug

    Also called Oxaliplatin, leucovorin, 5-fluorouracil

    Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1.

    Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1.

Study groups in NCT00613080
Study groupRoleWhat they receive
IMRT + Chemotherapy , Resection, Postoperative ChemotherapyOtherRadiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Receives: Drug: capecitabine; Drug: oxaliplatin; Procedure: resection; Radiation: radiation therapy; Drug: FOLFOX

What is being measured

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

  1. The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively

    The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.

    Measured: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Secondary outcomes (8)

  1. Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning

    Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.

    Measured: Pretreatment

  2. Number of Patients With Pathologic Complete Response

    Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.

    Measured: At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.

  3. Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;

    Measured: From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.

  4. Local-regional Failure: 4-year Rate

    Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.

    Measured: From registration to four years

  5. Distant Failure: 4-year Rate

    Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.

    Measured: From registration to four years

  6. Overall Survival: 4-year Rate

    Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From registration to four years

  7. Disease-free Survival: 4-year Rate

    Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.

    Measured: From registration to four years

  8. Number of Patients Who Underwent Abdominoperineal Resection

    All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.

    Measured: Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.

Timeline

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

  1. First posted12 Feb 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJan 2010
  4. Study completionDec 2016

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
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00613080
Sponsor's protocol ID
RTOG-0822
Other IDs
CDR0000586277
Status last verified
Jul 2018
First submitted
9 Feb 2008
Last updated
25 Sep 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine, oxaliplatin and resection in people with Colorectal Cancer, run by Radiation Therapy Oncology Group at 120 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Canada. 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 10 Jun 2013). 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?

The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively (time frame: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)). 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 NCT00613080.

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 25 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in