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NCT00227747 · CITED IN SOURCE DOCUMENTS

Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer

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
2021-02-17

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

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 * T3-4, N0-2, M0 disease by endorectal ultrasound * T2 disease located in the low rectum allowed provided lower pole is ≤ 6 cm from the anal verge * Tumor must be accessible to digital rectal examination (i.e., tumor located at low- or mid-rectum) * Resectable disease treatable with chemoradiotherapy * No unresectable disease (i.e., T4 disease with high risk for incomplete gross resection \[i.e., R2\]) PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin \> 10 g/dL Hepatic * Alkaline phosphatase normal * Bilirubin normal Renal * Creatinine ≤ 130 μmol/L * No severe renal insufficiency Cardiovascular * No cardiac insufficiency * No symptomatic coronary artery disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindication to study treatment * Prior acute intestinal obstruction allowed provided patient underwent surgical diversion with stoma * No history of other cancer except basal cell skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy * No uncontrolled diabetes * No other uncontrolled severe disease * No geographical, social, or psychological condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for cancer * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for cancer Surgery * Not specified Other * No concurrent phenytoin * No concurrent participation in another clinical trial of an experimental medical treatment
healthy Volunteers
false
maximum Age
80 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: capecitabine
    2. Drug: oxaliplatin
    3. Procedure: conventional surgery
    4. Procedure: neoadjuvant therapy
    5. Radiation: radiation therapy
    label
    Radiothérapie + Xelox
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: capecitabine
    2. Procedure: conventional surgery
    3. Procedure: neoadjuvant therapy
    4. Radiation: radiation therapy
    label
    Radiothérapie + Capécitabine
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Radiothérapie + Capécitabine
    2. Radiothérapie + Xelox
    name
    capecitabine
    type
    DRUG
  2. arm Group Labels
    1. Radiothérapie + Xelox
    name
    oxaliplatin
    type
    DRUG
  3. arm Group Labels
    1. Radiothérapie + Capécitabine
    2. Radiothérapie + Xelox
    name
    conventional surgery
    type
    PROCEDURE
  4. arm Group Labels
    1. Radiothérapie + Capécitabine
    2. Radiothérapie + Xelox
    name
    neoadjuvant therapy
    type
    PROCEDURE
  5. arm Group Labels
    1. Radiothérapie + Capécitabine
    2. Radiothérapie + Xelox
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
598
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Rate of complete surgical resection
secondary Outcomes
  1. measure
    Overall survival
  2. measure
    Disease-free survival
  3. measure
    Sphincter preservation
  4. measure
    Sphincter function
  5. measure
    Biological parameters that predict tumor response and treatment-related toxicity
  6. measure
    Acute and late toxicity
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
detailed Description
OBJECTIVES: Primary * Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and capecitabine with vs without oxaliplatin followed by total mesorectal excision, in terms of the rate of complete surgical resection, in patients with resectable stage II or III rectal cancer. Secondary * Compare overall and disease-free survival of patients treated with these regimens. * Compare clinical tumor response in patients treated with these regimens. * Compare acute and late toxicity of these regimens in these patients. * Determine biological parameters that predict tumor response and treatment-related toxicity in patients treated with these regimens. * Compare sphincter preservation and function in patients treated with these regimens. OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy once daily 5 days a week and receive capecitabine once daily 5 days a week in weeks 1-5. * Arm II: Patient undergo radiotherapy and receive capecitabine as in arm I. Patients also receive oxaliplatin once weekly in weeks 1-5. All patients undergo total mesorectal excision 6 weeks after completion of chemoradiotherapy. PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
Source references
references
  1. citation
    Gerard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, Francois E, de La Roche G, Bouche O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahe MA, Becouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol. 2010 Apr 1;28(10):1638-44. doi: 10.1200/JCO.2009.25.8376. Epub 2010 Mar 1.
    pmid
    20194850
    type
    RESULT
  2. citation
    Azria D, Doyen J, Jarlier M, Martel-Lafay I, Hennequin C, Etienne P, Vendrely V, Francois E, de La Roche G, Bouche O, Mirabel X, Denis B, Mineur L, Berdah J, Mahe M, Becouarn Y, Dupuis O, Lledo G, Seitz J, Bedenne L, Gourgou-Bourgade S, Juzyna B, Conroy T, Gerard J. Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer. Ann Oncol. 2017 Oct 1;28(10):2436-2442. doi: 10.1093/annonc/mdx351.
    pmid
    28961836
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        1">Evidence (preoperative oxaliplatin with chemoradiation therapy):</p> <div class="pdq-content-list"><ol id="_1056"><li>The <a href="/clinicaltrials/NCT00227747">ACCORD 12/0405-Prodige 2</a> trial (NCT00227747), which randomly assigned 598 patients with clinically staged T2 or T3 or resectable T4 rectal cancer accessib
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        adiation therapy):</p> <div class="pdq-content-list"><ol id="_1056"><li>The <a href="/clinicaltrials/NCT00227747">ACCORD 12/0405-Prodige 2</a> trial (NCT00227747), which randomly assigned 598 patients with clinically staged T2 or T3 or resectable T4 rectal cancer accessible by digital rectal examination to either preope
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      source string sha256
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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