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

Primary Purpose

Rectal Neoplasms

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Capecitabine
mFOLFOX6 or CAPOX
Sponsored by
LI XIN-XIANG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Rectal Neoplasms, Adjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Observation

5-fluorouracil

5-fluorouracil alone

mFOLFOX6 or CAPOX

Arm Description

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)

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 )

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)

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)

Outcomes

Primary Outcome Measures

Disease free survival
Calculated from the date of surgery to the date of recurrence

Secondary Outcome Measures

Overall survival
Calculated from the date of diagnosis to the date of death from any cause
Disease free survival
Calculated from the date of surgery to the date of recurrence
The rate of local recurrence
The ratio of the number of local recurrence to the total patients
The rate of adverse events resulted from chemotherapy
The ratio of the number of patients experienced adverse events to the total patients
The quality of life postoperatively
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

Full Information

First Posted
January 17, 2018
Last Updated
November 5, 2018
Sponsor
LI XIN-XIANG
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1. Study Identification

Unique Protocol Identification Number
NCT03415763
Brief Title
Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LI XIN-XIANG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Rectal Neoplasms, Adjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
764 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Arm Description
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)
Arm Title
5-fluorouracil
Arm Type
Experimental
Arm Description
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 )
Arm Title
5-fluorouracil alone
Arm Type
Experimental
Arm Description
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)
Arm Title
mFOLFOX6 or CAPOX
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 or CAPOX
Other Intervention Name(s)
5-Fu-leucovorin-oxaliplatin or xeloda-oxaliplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease free survival
Description
Calculated from the date of surgery to the date of recurrence
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Calculated from the date of diagnosis to the date of death from any cause
Time Frame
3-year, 5-year
Title
Disease free survival
Description
Calculated from the date of surgery to the date of recurrence
Time Frame
5-year
Title
The rate of local recurrence
Description
The ratio of the number of local recurrence to the total patients
Time Frame
3-year
Title
The rate of adverse events resulted from chemotherapy
Description
The ratio of the number of patients experienced adverse events to the total patients
Time Frame
3-year
Title
The quality of life postoperatively
Description
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
Time Frame
3-month, 6-month, 9-month, 12-month, 18-month, 24-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinxiang Li, MD,PhD
Phone
86-13918176716
Email
lxx1149@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qingguo Li, MD,PhD
Phone
86-18918298120
Email
13111230016@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinxiang Li, MD,PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinxiang Li, MD,PhD
Phone
86-13918176716
Email
lxx1149@163.com
First Name & Middle Initial & Last Name & Degree
Qingguo Li, MD,PhD
Phone
86-18918298120
Email
13111230016@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinxiang Li, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31729964
Citation
Li Q, Luo D, Zhu J, Yang L, Liu Q, Ma Y, Liang L, Cai S, Zhang Z, Li X; ACRNaCT study group. ACRNaCT trial protocol: efficacy of adjuvant chemotherapy in patients with clinical T3b/T4, N+ rectal Cancer undergoing Neoadjuvant Chemoradiotherapy: a pathology-oriented, prospective, multicenter, randomized, open-label, parallel group clinical trial. BMC Cancer. 2019 Nov 15;19(1):1117. doi: 10.1186/s12885-019-6289-6.
Results Reference
derived

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

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