Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC

Phase 3

Completed

• Conditions: Incidental Gallbladder Carcinoma; Biliary Tract Cancer
• Interventions: Drug: Gemcitabine; Drug: Cisplatin; Drug: Adjuvant chemotherapy; Procedure: Oncologically radical margin-free (R0) resection

• Registration Number: NCT03673072
• Lead Sponsor: Krankenhaus Nordwest

Brief Summary

Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC)

Detailed Description

The aim of the study is to investigate whether induction chemotherapy followed by radical re-resection (and - if possible - postoperative chemotherapy) in incidental gallbladder carcinoma (IGBC) or in front radical resection in biliary tract cancer (BTC) (intrahepatic cholangiocarcinoma (ICC)/ extrahepatic cholangiocarcinoma (ECC)) prolongs overall survival without impaired quality of life compared to immediate radical surgery alone with or without adjuvant chemotherapy (investigator's choice) in patients with IGBC, or BTC (ICC/ECC). One of the most important secondary objectives is to raise awareness for the necessity of a radical second surgery as well as to improve the adherence to the treatment guidelines in IGBC. Further secondary objectives are safety and tolerability of the treatment as well as quality of life.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2019-07-01
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (gemcitabine plus cisplatin)	Cisplatin	Patients assigned to arm A will receive treatment with gemcitabine plus cisplatin. Chemotherapy will be administered for 3 cycles preoperatively (neoadjuvant part) and for 3 cycles postoperatively (adjuvant part).
Arm A (gemcitabine plus cisplatin)	Oncologically radical margin-free (R0) resection	Patients assigned to arm A will receive treatment with gemcitabine plus cisplatin. Chemotherapy will be administered for 3 cycles preoperatively (neoadjuvant part) and for 3 cycles postoperatively (adjuvant part).
Arm B (standard postoperative management)	Oncologically radical margin-free (R0) resection	Patients assigned to arm B will receive surgery directly, without receiving perioperative chemotherapy (Standard of Care / SOC). After surgery, adjuvant chemotherapy can be administered by investigator's choice.
Arm B (standard postoperative management)	Adjuvant chemotherapy	Patients assigned to arm B will receive surgery directly, without receiving perioperative chemotherapy (Standard of Care / SOC). After surgery, adjuvant chemotherapy can be administered by investigator's choice.
Arm A (gemcitabine plus cisplatin)	Gemcitabine	Patients assigned to arm A will receive treatment with gemcitabine plus cisplatin. Chemotherapy will be administered for 3 cycles preoperatively (neoadjuvant part) and for 3 cycles postoperatively (adjuvant part).

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint is overall survival (OS)	up to 6 years follow-up

Secondary Outcome Measures

Name	Time	Method
Number of patients with any serious perioperative morbidity or mortality	up to 30 and 90 days after surgery
PFS (Progression free surviva) rates at 3 and 5 years	at 3 and 5 years after randomization
Toxicity, graded using CTC adverse events criteria version CTCAE V 5.0	up to 6 years after randomization
Quality of life (EORTC QLQ-C30)	every 3 weeks until EOT andt then every 3 months up to 6 years of follow-up	"European Organisation for the Research and Treatment of Cancer" Quality of Life Questionnaire Core 30. The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.; The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.; Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.; Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
OS (overall survival) rates at 3 and 5 years	at 3 and 5 years after randomization
Progression free survival (PFS)	up to 6 years after randomization
R0- resection rate	2 weeks after surgery (Arm A: 14 weeks after randomization; Arm B: 2 weeks after randomization)

Trial Locations

Locations (1)

Krankenhaus Nordwest gGmbH; 🇩🇪 Frankfurt, Germany