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Lymphadenectomy for Gallbladder Cancer

Marshfield Medical Center-River Region at Stevens Point, Stevens Point, WI
Gallbladder Cancer+5 More ConditionsLymphadenectomy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether adding chemotherapy before and after surgery is better than just after surgery for treating gallbladder cancer.

Eligible Conditions
  • Stage IIB Gallbladder Cancer
  • Stage III Gallbladder Cancer
  • Stage IIIB Gallbladder Cancer
  • Stage IIIA Gallbladder Cancer
  • Stage II Gallbladder Cancer
  • Stage IIA Gallbladder Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

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1
Cisplatin
1
Celecoxib
1
HIPEC

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Year 5
Resectability rate
Year 5
Incidence of residual disease
Year 5
Difference in progression-free survival
Year 5
Difference in overall survival
Up to 5 years
Overall resectability rate

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cisplatin
1
Celecoxib
1
HIPEC

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Arm I (surgery, adjuvant therapy)
1 of 2
Arm II (neoadjuvant therapy, surgery, adjuvant therapy)
1 of 2

Active Control

Experimental Treatment

186 Total Participants · 2 Treatment Groups

Primary Treatment: Lymphadenectomy · No Placebo Group · Phase 2 & 3

Arm II (neoadjuvant therapy, surgery, adjuvant therapy)Experimental Group · 4 Interventions: Cisplatin, Lymphadenectomy, Partial Hepatectomy, Gemcitabine Hydrochloride · Intervention Types: Drug, Procedure, Procedure, Drug
Arm I (surgery, adjuvant therapy)ActiveComparator Group · 4 Interventions: Cisplatin, Lymphadenectomy, Partial Hepatectomy, Gemcitabine Hydrochloride · Intervention Types: Drug, Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Lymphadenectomy
2007
Completed Phase 2
~750
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
110 Previous Clinical Trials
173,499 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,275 Previous Clinical Trials
41,234,626 Total Patients Enrolled
Shishir K MaithelPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have had another cancer in the past or currently have another cancer, you may still be eligible for the trial as long as it will not interfere with the study's ability to evaluate the effectiveness and safety of the new treatment.
References

Frequently Asked Questions

What is the standard procedure for Lymphadenectomy?

"Lymphadenectomy, which is the surgical removal of lymph nodes, is most often used to treat neoplasm metastasis. However, it is also a viable option for treating small cell lung cancer (sclc), urinary bladder, and advanced testicular cancer." - Anonymous Online Contributor

Unverified Answer

Are there other scientific papers which explore Lymphadenectomy in detail?

"Out of the 1064 active clinical trials studying Lymphadenectomy, 361 are in Phase 3. The majority of these Lymphadenectomy trials are based in Shanghai; however, there are 53176 total locations running trials for Lymphadenectomy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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