Adjuvant chemotherapy for stage III rectal cancer after neoadjuvant treatment
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
This study is testing whether adding oxaliplatin to the standard chemotherapy for stage III rectal cancer after initial treatment can help patients live longer and reduce the chance of cancer coming back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 764 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT03415763 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adjuvant chemotherapy in patients with clinical stage III rectal cancer who have undergone neoadjuvant chemoradiotherapy. It aims to determine the long-term outcomes of patients based on their postoperative pathological stage, comparing those who receive 5-fluorouracil alone to those receiving a combination of oxaliplatin and 5-fluorouracil. The study is designed as a non-inferiority trial to assess the impact of adjuvant chemotherapy on local recurrence and overall survival. The research seeks to clarify the role of adjuvant chemotherapy in rectal cancer treatment, which remains controversial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed clinical stage III rectal cancer who have not undergone pelvic irradiation.
Not a fit: Patients with severe comorbidities, those with multiple primary cancers, or those who have undergone recent steroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and reduce recurrence in patients with stage III rectal cancer.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of adjuvant chemotherapy in rectal cancer, making this approach both relevant and necessary to explore further.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xinxiang Li, MD,PhD — Fudan University
- Study coordinator: Xinxiang Li, MD,PhD
- Email: lxx1149@163.com
- Phone: 86-13918176716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.