A Phase II Trial of Radiotherapy Combined With Raltitrexed and Irinotecan(CPT-11) in Patients With Metastatic or Locally Recurrent Colorectal Cancer
Sponsor study identifier
interventional
30
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
August 1, 2020
Actual (reported)Study Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. The patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)July 31, 2020
Actual (reported)August 1, 2020
Actual (reported)August 5, 2020
Actual (reported)December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)
20 weeks
DCR(Disease Control Rate)
20 weeks
PFS(Progression Free Survival)
24 months
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
20 weeks
Each cycle lasts 3 weeks. Administration of Raltitrexed and Irinotecan weekly followed by a 2 week 'rest' period with no drug given. Raltitrexed is given by IV infusion at a dose of 3mg/m2. Irinotecan is given by IV infusion at a dose of 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7).Radiation: 45-55Gy/25-30Fx
Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) per week. Radiation: 45-55Gy/25-30Fx
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Radiotherapy Combined With Raltitrexed and Irinotecan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200023, China
Zhen Zhang, MD
Fudan University
30 participants (actual enrollment reported by the registry).
First Submitted
July 31, 2020
First Posted
August 5, 2020
Study Start
January 1, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 1, 2020
Actual (reported)Study Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 5, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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