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Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma

NCT02935309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-31

No results posted yet for this study

Summary

This research study is designed to see if Capecitabine and Lenvatinib in combination with external radiation therapy are effective in treating locally advanced rectal adenocarcinoma in patients who have not yet had surgery, and what the best dosage is.

Conditions

Interventions

DRUG

Lenvatinib

Pre-surgery Lenvatinib, days 1 - 5. Dose Escalation Levels: 1.) 10 mg by mouth (PO) daily (QD); 2.) 14 mg PO QD; 3.) 20 mg PO QD; 4.) 24 PO QD.

DRUG

Capecitabine

Pre-surgery Capecitabine, 850 mg/m\^2, twice a day (BID) on days 1-5 for 5½ -6 weeks.

RADIATION

External Radiation Therapy (XRT)

Pre-surgery RT: Participants will receive 6 weeks of radiation therapy. The radiation sessions will be daily, Monday through Friday, except for holidays.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Richard Kim, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-14
Primary Completion
2019-10-11
Completion
2020-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935309 on ClinicalTrials.gov