Study of Vitamin D in Untreated Metastatic Colorectal Cancer

Part of paid clinical trials in Boise, Idaho.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT01516216
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a prospective, randomized, double-blind phase II trial to evaluate the efficacy and safety of two doses of vitamin D supplementation in combination with standard chemotherapy in participants with previously-untreated metastatic colorectal adenocarcinoma.

Key Dates

First listed
Jan 24, 2012
Start date
Apr 13, 2012
Status verified
Apr 2022
Primary completion
Nov 9, 2019
Completion
Nov 9, 2019

Study Design

Enrollment
139 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Chemotherapy + Standard Dose Vitamin D
    FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.
  • Active Comparator: Chemotherapy + Higher Dose
    FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose. Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.

Primary Outcome Measure

Median Progression-free Survival (PFS) [ Time Frame: Disease was evaluated every 4 cycles on treatment and off treatment every 8-16 weeks until PD or non-protocol therapy start if discontinued for reason other than PD. Participants were observed up to 28.5 months with maximum follow-up of 56.7 months. ]

Locations (18)

FacilityCityStateZIPSite coordinators
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoiseIdaho83712-
Mountain States Tumor Institute- FruitlandFruitlandIdaho83619-
Mountain States Tumor Institute - MeridianMeridianIdaho83642-
Mountain States Tumor Institute- NampaNampaIdaho83686-
Mountain States Tumor Institute- Twin FallsTwin FallsIdaho83301-
The Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois--
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02115-
Lowell General HospitalLowellMassachusetts--
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical CenterMilfordMassachusetts--
Newton-Wellesley HospitalNewtonMassachusetts--
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore HospitalSouth WeymouthMassachusetts--
New Hampshire Oncology Hematology-P.A.ConcordNew Hampshire--
New Hampshire Oncology Hematology-P.A.HooksettNew Hampshire--
New Hampshire Oncology Hematology-P.A.LaconiaNew Hampshire--
Dana-Farber/New Hampshire Oncology-HematologyLondonderryNew Hampshire--
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Boise, ID

By research site
Mountain States Tumor Institute at St. Luke's Regional Medical Center· Boise, IDMountain States Tumor Institute- Fruitland· Fruitland, IDMountain States Tumor Institute - Meridian· Meridian, IDMountain States Tumor Institute- Nampa· Nampa, IDMountain States Tumor Institute- Twin Falls· Twin Falls, IDThe Robert H. Lurie Comprehensive Cancer Center of Northwestern University· Chicago, IL

Related Studies