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

Rectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03415763
• Other study ID #: Fudan AC
• Status: Recruiting
• Phase: Phase 3
• Start date: November 5, 2018
• Est. completion date: December 2025

Study information

• Verified date: November 2018
• Source: Fudan University
• Contact: Xinxiang Li, MD,PhD
• Phone: 86-13918176716
• Email: lxx1149[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 764
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
LI XIN-XIANG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	Calculated from the date of surgery to the date of recurrence	3-year
Secondary	Overall survival	Calculated from the date of diagnosis to the date of death from any cause	3-year, 5-year
Secondary	Disease free survival	Calculated from the date of surgery to the date of recurrence	5-year
Secondary	The rate of local recurrence	The ratio of the number of local recurrence to the total patients	3-year
Secondary	The rate of adverse events resulted from chemotherapy	The ratio of the number of patients experienced adverse events to the total patients	3-year
Secondary	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	3-month, 6-month, 9-month, 12-month, 18-month, 24-month