Who is sponsoring NCT02270606?

NCT02270606 is sponsored by Virginia Commonwealth University.

What drugs are being tested in NCT02270606?

Interventions in NCT02270606: intensity-modulated radiation therapy, fluorouracil, oxaliplatin, leucovorin calcium, therapeutic conventional surgery.

What condition does NCT02270606 study?

NCT02270606 studies Mucinous Adenocarcinoma of the Rectum, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Rectum, Rectal Adenocarcinoma, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage IIIA Rectal Cancer, Stage IIIB Rectal Cancer, Stage IIIC Rectal Cancer.

Is NCT02270606 still recruiting?

NCT02270606 is currently completed. Last updated 20 July 2021.

Last reviewed 2021-07-20 · How we verify

NCT02270606

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer

Completed Phase 1 Last updated 20 July 2021

What this trial tests

Phase 1 trial testing intensity-modulated radiation therapy in Mucinous Adenocarcinoma of the Rectum in 14 participants. Completed in 13 May 2021.

Timeline

4 December 2014

Primary endpoint
14 May 2018

13 May 2021

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	4 December 2014
Primary completion	14 May 2018
Estimated completion	13 May 2021
Sites	1 location across United States

Drugs / interventions tested

intensity-modulated radiation therapy
fluorouracil — full drug profile →
oxaliplatin (Oxaliplatin) — full drug profile →
leucovorin calcium — full drug profile →
therapeutic conventional surgery

Conditions studied

Mucinous Adenocarcinoma of the Rectum — all drugs for Mucinous Adenocarcinoma of the Rectum →
Recurrent Rectal Cancer — all drugs for Recurrent Rectal Cancer →
Signet Ring Adenocarcinoma of the Rectum — all drugs for Signet Ring Adenocarcinoma of the Rectum →
Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →

Sponsor

Virginia Commonwealth University

Who can join

18 and older, any sex, with Mucinous Adenocarcinoma of the Rectum or Recurrent Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving additional combination chemotherapy after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil followed by combination chemotherapy before and after surgery may be a better treatment for rectal cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of intensity-modulated radiation therapy

Trials testing the same drug.

NCT05388773 — Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cance · Phase 2 · recruiting
NCT03196869 — the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasophar · Phase 2 · unknown
NCT02186470 — Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Respon · NA · completed
NCT02048020 — Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV · Phase 2 · completed
NCT01470365 — 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent T · Phase 1 · completed

Other Virginia Commonwealth University trials

Trials by the same sponsor.

NCT05936931 — Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening · NA · not yet recruiting
NCT07365839 — Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma · Phase 1 · not yet recruiting
NCT07178158 — Enhancing Addiction Treatment Through Psychoeducation · NA · not yet recruiting
NCT07531316 — Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers · Phase 1 · not yet recruiting
NCT07426913 — Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02270606 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Virginia Commonwealth University
Last refreshed: 20 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02270606.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing