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Platinum-based chemotherapy

Cisplatin for Anal Cancer (InterAACT Trial)

Phase 2

Waitlist Available

Led By Cathy Eng

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

InterAACT Trial Summary

This trial is comparing two different chemotherapy drug combinations to see which one is more effective in treating anal cancer.

Eligible Conditions

Anal Cancer
Anal Canal Cancer
Anal Canal Carcinoma
Anal Carcinoma

InterAACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best ORR defined as the percentage of patients achieving confirmed partial (PR) or complete responses (CR) as per RECIST v1.1

Secondary outcome measures

Anti-tumor activity and magnitude of response

Best ORR of non-irradiated lesions defined as the percentage of patients achieving confirmed PR or CR as per RECIST v1.1 of non-irradiated sites of disease

Changes in QOL

+8 more

Other outcome measures

Biomarkers, Tumor

InterAACT Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (paclitaxel, carboplatin)Experimental Treatment4 Interventions

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (cisplatin, fluorouracil or capecitabine)Experimental Treatment5 Interventions

Patients receive cisplatin IV over 1-4 hours on day 1 and fluorouracil IV continuously over 24 hours on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with complications associated with the central venous access which prevent further infusion of fluorouracil and only after discussion with the Chief Investigator receive capecitabine BID on days 1-4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Capecitabine

2013

Completed Phase 3

~3420

Paclitaxel

2011

Completed Phase 4

~5380

Fluorouracil

2014

Completed Phase 3

~11540

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,831 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,062 Total Patients Enrolled

Cathy EngPrincipal InvestigatorECOG-ACRIN Cancer Research Group

3 Previous Clinical Trials

352 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cisplatin been tested in other clinical experiments?

"As of now, 1981 clinical studies are being conducted that involve Cisplatin with 613 trials in the third phase. Most of these examinations take place in Guangzhou, Guangdong but there is an extensive network of 98347 sites running tests for this drug."

Answered by AI

Has the Federal Drug Administration sanctioned Cisplatin for medical use?

"Informed by scientific data and given the Phase 2 designation of this trial, our team at Power gave Cisplatin a safety rating of two. While there is evidence supporting its safety, no studies exist that verify its efficacy."

Answered by AI

How many participants are being recruited to take part in this research endeavor?

"Unfortunately, this clinical trial has concluded enrolment. According to the records posted on 2/1/2016 and last edited 12/29/2021, there are no longer any openings for participants in this study. Nevertheless, patients with metastatic anal canal carcinoma can still find 3293 active trials while 1981 studies that utilize Cisplatin continue admission of volunteers."

Answered by AI

Is this experiment presently seeking volunteers?

"According to clinicaltrials.gov, the recruitment period for this study has concluded; although it was initially hosted on February 1st 2016 and last updated December 29th 2021. Nonetheless, over 5000 other trials are currently enrolling patients."

Answered by AI

To what ailments is Cisplatin regularly administered?

"Cisplatin is widely used in initial treatments and can also be employed to treat various ailments such as metastatic bladder cancer, refractory fallopian tube carcinoma, or advanced testicular cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cisplatin and Fluorouracil Compared With Carboplatin and Paclitaxel in Treating Patients With Inoperable Locally Recurrent or Metastatic Anal Cancer

2016. "Cisplatin and Fluorouracil Compared With Carboplatin and Paclitaxel in Treating Patients With Inoperable Locally Recurrent or Metastatic Anal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02560298.

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