Autopsy report · NCT02121405

Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM

“DSMB stopped this trial due to the difference of 3-year DFS's rate between two groups more than 5% at the interim analysis in July 2021.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 6 months before it started.
• Suspended: paused, and may or may not restart.
• 350 participants planned (an estimate, not an actual count).

Vital statistics

Status

Suspended

Phase

Phase 3

Sponsor

Zhejiang University

Sponsor type

University, hospital or other

Conditions

Colorectal Neoplasm; Effects of Radiation Therapy; Effects of Chemotherapy; Surgery

Interventions

Rectectomy; Radiotherapy; Capecitabine; Oxaliplatin

Participants

350 (planned, not actual)

Sites

7

Countries

China

Trials that died the same way

• Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
  “DSMB stopped trial for futility” (71% match in meaning)
• Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
  “DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.” (67% match in meaning)
• ATG Plus Low-dose PT-Cy for GVHD Prevention
  “DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.” (67% match in meaning)
• Soy Protein/Effexor Hormone Therapy for Prostate Cancer
  “Stopped by the DSMB for lack of effect per interim stopping rule.” (66% match in meaning)
• Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
  “NINDS DSMB recommended trial be terminated for futility after reviewing an interim analysis of 84 subjects.” (65% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.