Status:
UNKNOWN
Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
Lead Sponsor:
LI XIN-XIANG
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 postoperativ...
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 respon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
764 Patients enrolled
Trial Details
Trial ID
NCT03415763
Start Date
November 5 2018
End Date
December 1 2025
Last Update
November 6 2018
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032