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NCT00003422 · CITED IN SOURCE DOCUMENTS

Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-12-04

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumor within 15 cm of anal verge) * Tumor considered potentially operable * No evidence of metastases indicated by liver ultrasound or CT scan; chest x-ray; or renal, liver, and bone profiles PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No uncontrolled heart failure or angina Other: * No other concurrent uncontrolled medical illness (e.g., infection) * No other prior or concurrent malignancy likely to interfere with the protocol treatments or comparisons PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
healthy Volunteers
false
maximum Age
75 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    fluorouracil
    type
    DRUG
  2. name
    leucovorin calcium
    type
    DRUG
  3. name
    adjuvant therapy
    type
    PROCEDURE
  4. name
    conventional surgery
    type
    PROCEDURE
  5. name
    neoadjuvant therapy
    type
    PROCEDURE
  6. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
1800
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Local recurrence by biopsy, imaging, or imaging and carcinoembryonic antigen result
secondary Outcomes
  1. measure
    Local recurrence-free survival
  2. measure
    Overall survival
  3. measure
    Time to appearance of distant metastases
  4. measure
    Disease-free survival
  5. measure
    Morbidity
  6. measure
    Quality of life
  7. measure
    Economic implications
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed.
detailed Description
OBJECTIVES: * Compare local recurrence free rates and quality of life in patients with operable rectal cancer receiving preoperative radiotherapy versus patients receiving selective postoperative chemoradiotherapy. * Determine local recurrence free survival, overall survival, time to appearance of distant metastases, disease free survival and morbidity in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by a number of factors including surgeon. Patients are randomized to receive preoperative radiotherapy (arm I) or postoperative chemoradiotherapy (arm II). * Arm I: Patients receive radiotherapy in 5 fractions over 1 week prior to surgery. Patients undergo surgery within 7 days of the last fraction of radiotherapy. * Arm II: Patients receive chemoradiotherapy 4-12 weeks after surgery (if circumferential resection margins are histologically involved by tumor). Radiotherapy is administered in 25 fractions over 5 weeks (5 days per week). During radiotherapy, patients either receive fluorouracil (5-FU) continuous infusion, 5-FU bolus IV and leucovorin calcium IV weekly, or a 5-day bolus schedule of 5-FU and leucovorin calcium. Patients may then receive adjuvant chemotherapy as per local policy. Quality of life assessments are made every 3 months for 1 year and then every 6 months for the next 2 years. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 1800 patients will be accrued into this study.
Source references
references
  1. citation
    Stephens RJ, Thompson LC, Quirke P, Steele R, Grieve R, Couture J, Griffiths GO, Sebag-Montefiore D. Impact of short-course preoperative radiotherapy for rectal cancer on patients' quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial. J Clin Oncol. 2010 Sep 20;28(27):4233-9. doi: 10.1200/JCO.2009.26.5264. Epub 2010 Jun 28.
    pmid
    20585099
    type
    RESULT
  2. citation
    Quirke P, Steele R, Monson J, Grieve R, Khanna S, Couture J, O'Callaghan C, Myint AS, Bessell E, Thompson LC, Parmar M, Stephens RJ, Sebag-Montefiore D; MRC CR07/NCIC-CTG CO16 Trial Investigators; NCRI Colorectal Cancer Study Group. Effect of the plane of surgery achieved on local recurrence in patients with operable rectal cancer: a prospective study using data from the MRC CR07 and NCIC-CTG CO16 randomised clinical trial. Lancet. 2009 Mar 7;373(9666):821-8. doi: 10.1016/S0140-6736(09)60485-2.
    pmid
    19269520
    type
    RESULT
  3. citation
    Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.
    pmid
    19269519
    type
    RESULT
  4. citation
    Quirke P, Sebag-Montefiore D, Steele R, et al.: Local recurrence after rectal cancer resection is strongly related to the plane of surgical dissection and is further reduced by pre-operative short course radiotherapy. Preliminary results of the Medical Research Council (MRC) CR07 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3512, 2006.
    type
    RESULT
  5. citation
    Sebag-Montefiore D, Steele R, Quirke P, et al.: Routine short course pre-op radiotherapy or selective post-op chemoradiotherapy for resectable rectal cancer? Preliminary results of the MRC CR07 randomised trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3511, 2006.
    type
    RESULT
  6. citation
    Sebag-Montefiore D: An update report on the MRC CR07 trial. [Abstract] Br J Cancer 85 (suppl 1): A-9.3, 28, 2001.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        the United Kingdom and the National Cancer Institute of Canada built on the short-course experience and conducted a randomized study (<a href="/clinicaltrials/NCT00003422">MRC CR07</a> and <a href="/clinicaltrials/NCT00003422">NCIC-CTG C016</a> [NCT00003422]) that compared short-course preoperative radiation therapy with se
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        Canada built on the short-course experience and conducted a randomized study (<a href="/clinicaltrials/NCT00003422">MRC CR07</a> and <a href="/clinicaltrials/NCT00003422">NCIC-CTG C016</a> [NCT00003422]) that compared short-course preoperative radiation therapy with selective postoperative chemoradiation therapy.[<a href="#
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      3. context exact
        e experience and conducted a randomized study (<a href="/clinicaltrials/NCT00003422">MRC CR07</a> and <a href="/clinicaltrials/NCT00003422">NCIC-CTG C016</a> [NCT00003422]) that compared short-course preoperative radiation therapy with selective postoperative chemoradiation therapy.[<a href="#cit/section_7.8">8</a>] In the
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      source title
      Rectal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice