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Search / Trial NCT03415763

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

Launched by LI XIN-XIANG · Jan 23, 2018

Trial Information

Current as of June 22, 2025

Recruiting

Keywords

Rectal Neoplasms Adjuvant Chemotherapy Neoadjuvant Chemoradiotherapy

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called adjuvant chemotherapy for patients with stage III rectal cancer who have already received another treatment called neoadjuvant chemoradiotherapy. In simpler terms, this means that the trial is looking at whether giving chemotherapy after surgery can help improve the outcome for patients who have had this type of cancer.

To participate in this trial, patients need to be between the ages of 18 and 75 and have a confirmed diagnosis of rectal cancer, which must be located within 12 centimeters of the anus. They also need to have been assessed by imaging tests like CT or MRI to ensure their cancer is at stage III and has not spread to other organs. Participants can expect to undergo treatment and regular check-ups to monitor their health. It's important to know that certain conditions, like pregnancy or severe health issues, may prevent someone from being eligible for this study.

Gender

ALL

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.

About Li Xin Xiang

Li Xin-Xiang is a prominent clinical trial sponsor dedicated to advancing medical research and innovation. With a strong commitment to improving patient outcomes, the organization specializes in designing and conducting high-quality clinical trials across various therapeutic areas. By leveraging a collaborative approach with leading healthcare professionals and research institutions, Li Xin-Xiang aims to accelerate the development of new therapies while ensuring adherence to the highest ethical and regulatory standards. Their focus on patient safety, data integrity, and scientific rigor positions them as a trusted partner in the global clinical research landscape.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Xinxiang Li, MD,PhD

Principal Investigator

Fudan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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