UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer

• Sponsor: Fudan University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03824899
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18.7
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Diagnostic Test: Blood concentration check	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Application of UGT1A1 Genotype Combined With Pharmacokinetics of SN-38 in the Detection of Irinotecan-based Neoadjuvant Chemoradiotherapy in Patients With Advanced Rectal Cancer
• Actual Study Start Date: Oct 10, 2018
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT group Patients With Advanced Rectal Cancer receiving CPT-11-based CRT and blood concentration check	Diagnostic Test: Blood concentration check; Blood concentration check：the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion

Outcome Measures

Primary Outcome Measures

1. the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 [During the chemoradiation weekly，assessed up to 5 weeks]

   the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

2. pathological response rate [Surgery scheduled 6-8 weeks after the end of chemoradiation]

   pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• pathological confirmed adenocarcinoma

• clinical stage T3-4 and/or N+

• the distance from anal verge less than 12 cm

• without distance metastases

• performance status score: 0~1

• UGT1A1*28 6/6 or 6/7

• without previous anti-cancer therapy

• sign the inform consent

Exclusion Criteria:

• pregnancy or breast-feeding women

• serious medical illness

• baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^{9/L, Hb≥90g/L, PLT≥100×10}9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

• DPD deficiency

• UGT1A1*28 7/7

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Zhen Zhang, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhu Ji, professor, Fudan University
• ClinicalTrials.gov Identifier: NCT03824899
• Other Study ID Numbers: FDRT-010
• First Posted: Jan 31, 2019
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhu Ji, professor, Fudan University: neoadjuvant chemoradiotherapy; irinotecan; SN-38
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jan 31, 2019