Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 23, 2021

Primary Completion Date

October 9, 2023

Study Completion Date

October 31, 2026

Conditions
Rectal Adenocarcinoma
Interventions
DRUG

Capecitabine

Capecitabine 825 mg/m\^2 twice daily orally 5 days per week on days of planned radiation therapy.

RADIATION

Radiation Therapy

Participants will receive varying doses of radiotherapy based on MRI guidance, beginning at 28-33 fractions (1.8 Gray units) .

DRUG

FOLFOX regimen

Standard of Care FOLFOX regimen consists of 8 cycles (each cycle is 14 days) of 5-fluorouracil, leucovorin, and oxaliplatin. Dosage is as follows: Oxaliplatin 85 mg/m\^2 IV over 2 hours day 1 each cycle. Leucovorin (optional) 400 mg/m\^2 IV over 2 hours day 1 each cycle. 5-fluorouracil bolus\* (optional) 400 mg/m\^2 IV push day 1 of each cycle, and 5-fluorouracil infusion 2400 mg/m\^2 IV continuous infusion over 46 hours day 1 each cycle.

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Viewray Inc.

INDUSTRY

collaborator

Natera, Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT05108428 - Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma | Biotech Hunter | Biotech Hunter