Clinical trial · Interventional
Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
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
NCT03415763CI-TRIAL-00035642unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| mFOLFOX6 or CAPOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Observation
- 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)
- type
- EXPERIMENTAL
- label
- 5-fluorouracil
- 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 )
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLi 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. PMID 31729964