NCT01215500

Brief Summary

Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy. The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

13.2 years

First QC Date

August 2, 2010

Last Update Submit

September 10, 2018

Conditions

TumorCancerMelanomaSarcomaCarcinoma

Keywords

solid tumor cancerepithelial carcinoma

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicities

    The dose limiting toxicities occurring within the initial observation period will be defined.

    30-90 days

  • maximum tolerated dose of hypofractionated RT

    30-90 days

Study Arms (1)

Radiation therapy

EXPERIMENTAL
Radiation: Hypofractionated RT

Interventions

Hypofractionated RTRADIATION

RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy: For all sites the dose levels are as follows: 1. 8 Gy/ fraction x 3 fractions = 24 Gy 2. 10 Gy/fraction x 3 fractions = 30 Gy 3. 12 Gy/fraction x 3 fractions = 36 Gy 4. 14 Gy/fraction x 3 fractions = 42 Gy 5. 16 Gy/fraction x 3 fractions = 48 Gy 6. 18 Gy/fraction x 3 fractions = 52 Gy 7. 20 Gy/fraction x 3 fractions = 60 Gy

Radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma)
  • Age 18 years and older
  • Life expectancy of \> 3 months
  • Patients with AJCC (6th edition, 2002) stage IV cancer with distant metastases and without pleural or pericardial effusion at diagnosis and before start of study
  • Patients with 1-5 sites of maximum tumor dimension (for each individual site) of ≤ 10 cm or \< 500 cc volume and amenable to radiation therapy as seen on standard imaging
  • Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required
  • Brain metastases must have been treated prior to enrollment on study, preferably with stereotactic radiosurgery
  • ECOG performance status ≤ 2 or Karnofsky Performance Status ≥ 60%
  • No prior radiation therapy to currently involved tumor sites
  • Room air saturation \> 90%
  • Hemoglobin \> 9.0 g/dl
  • ANC \>=1,500/microliter
  • Platelets \>=100,000/microliter
  • Total bilirubin within institutional limits
  • Albumin \> 2.9 g/dl
  • +3 more criteria

You may not qualify if:

  • Uncontrolled intercurrent illness
  • Patients with significant atelectasis such that CT definition of gross tumor volume is difficult to determine
  • Pregnancy or breast feeding
  • Patients must have no uncontrolled active infection other than that not curable with treatment of their cancer.
  • Patients may not be receiving any other investigational drugs during RT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

NeoplasmsMelanomaSarcomaCarcinoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms, Glandular and Epithelial

Study Officials

  • Steven Chmura, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2010

First Posted

October 6, 2010

Study Start

January 1, 2005

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations

US(1)