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Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03415763
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
LI XIN-XIANG, Fudan University

Brief Summary:
The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Drug: Capecitabine Drug: mFOLFOX6 or CAPOX Phase 3

Detailed Description:
Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 764 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Pathology-oriented, Prospective, Multicenter, Randomized, Open-label, Parallel Group Clinical Trial
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Observation
Observation for patients with pathological complete response or yp stage I(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil)
Experimental: 5-fluorouracil
Capecitabine for patients with pathological complete response or yp stage I Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil )
Drug: Capecitabine
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Other Name: Xeloda

Experimental: 5-fluorouracil alone
5-fluorouracil alone for patients with yp stage II or III Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone)
Drug: Capecitabine
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Other Name: Xeloda

Experimental: mFOLFOX6 or CAPOX
Oxaliplatin combined with 5-fluorouracil for patients with yp stage II or III mFOLFOX6 (leucovorin 400 mg/m2 as a 2-hour infusion, and the concurrent administration of oxaliplatin 85 mg/m2 as a 2-hour infusion, followed by a bolus of 5-FU 400 mg/m2 within 15 min and 46-hour infusion of 5-FU 2400 mg/m2 on day 1 every 2 weeks), three cycles or CAPOX (oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, followed by capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks), three cycles( According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone)
Drug: mFOLFOX6 or CAPOX
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Other Name: 5-Fu-leucovorin-oxaliplatin or xeloda-oxaliplatin




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3-year ]
    Calculated from the date of surgery to the date of recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3-year, 5-year ]
    Calculated from the date of diagnosis to the date of death from any cause

  2. Disease free survival [ Time Frame: 5-year ]
    Calculated from the date of surgery to the date of recurrence

  3. The rate of local recurrence [ Time Frame: 3-year ]
    The ratio of the number of local recurrence to the total patients

  4. The rate of adverse events resulted from chemotherapy [ Time Frame: 3-year ]
    The ratio of the number of patients experienced adverse events to the total patients

  5. The quality of life postoperatively [ Time Frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month ]
    The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The lesion must be within 12 cm of the anus as measured by endoscopy
  • Histologically confirmed diagnosis of rectal carcinoma
  • CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs
  • Without multiple primary cancer
  • Sufficient organ function
  • Able to provide written informed consent

Exclusion Criteria:

  • Younger than 18 years or older than 75 years
  • Synchronous or metachronous malignancy within 5 years.
  • Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
  • Patients with a history of pelvic irradiation.
  • ASA grade IV or V.
  • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding.
  • Severe mental illness.
  • Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
  • Patients who received steroid therapy within one month.
  • Patients or family members misunderstand the conditions and goals of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415763


Contacts
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Contact: Xinxiang Li, MD,PhD 86-13918176716 lxx1149@163.com
Contact: Qingguo Li, MD,PhD 86-18918298120 13111230016@fudan.edu.cn

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xinxiang Li, MD,PhD    86-13918176716    lxx1149@163.com   
Contact: Qingguo Li, MD,PhD    86-18918298120    13111230016@fudan.edu.cn   
Principal Investigator: Xinxiang Li, MD,PhD         
Sponsors and Collaborators
LI XIN-XIANG
Investigators
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Principal Investigator: Xinxiang Li, MD,PhD Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LI XIN-XIANG, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03415763    
Other Study ID Numbers: Fudan AC
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LI XIN-XIANG, Fudan University:
Rectal Neoplasms
Adjuvant Chemotherapy
Neoadjuvant Chemoradiotherapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances