NCT02120118

Brief Summary

The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment failure solid tumors are tumor response rate, while secondary goals are rates of acute and late adverse effects, local control rate, distant metastasis rate, progression-free rate and overall survival rate.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 9, 2015

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

March 17, 2014

Last Update Submit

June 8, 2015

Conditions

Solid Tumors

Keywords

Treatment failure

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate

    To estimate the tumor response rate (complete response + partial response; CR + PR; according to RECIST criteria version 1.1).

    12 weeks

Secondary Outcomes (3)

  • Adverse events

    up to 12 weeks

  • Late adverse events

    up to 1 years

  • Time to Disease Progression

    up to 5 years

Study Arms (1)

Radiation; Hyperthermia; Chemotherapy

EXPERIMENTAL

Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.

Radiation: RadiationOther: HyperthermiaDrug: CisplatinDrug: Taxotere

Interventions

RadiationRADIATION

2Gy/5fx/week for a subtotal of 40Gy/20fx/4 weeks, followed by reduced-field boost with 10Gy/2fx/2 weeks (5Gy once a week during 5th and 6th week), totalling 50Gy/22fx/6 weeks.

Radiation; Hyperthermia; Chemotherapy
HyperthermiaOTHER

42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times

Radiation; Hyperthermia; Chemotherapy
CisplatinDRUG

30mg/m2

Radiation; Hyperthermia; Chemotherapy
TaxotereDRUG

20mg/m2

Radiation; Hyperthermia; Chemotherapy

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 20-85 years, with ECOG performance 0-2.
  • Treatment failure solid tumor(s), with histologically or clinically confirmed recurrence or progression after primary treatment of either single modality of surgery, chemotherapy or radiotherapy or any combinations.
  • Complete surgical excision is NOT feasible as salvage treatment for the recurrent or progressive tumor(s), or the patient does NOT agree to receive the surgical procedure.
  • Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
  • Measurable lesions by image examinations or endoscopy within 2 months.
  • The distribution of the lesions of interest does NOT exceed 20cm range.
  • The patient can tolerate implementation of cisplatin and taxotere weekly therapy, with respect to hematopoietic status, renal function, liver function, allergy and other potential adverse effects.

You may not qualify if:

  • Re-irradiation of 50Gy/22fx is considered NOT tolerable.
  • Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
  • The patient is participating in other clinical trials.
  • Future regular clinical follow-up is NOT possible.
  • The patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers).
  • The patient has pacemakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 11101, Taiwan

Location

MeSH Terms

Interventions

RadiationDiathermyCisplatinDocetaxel

Intervention Hierarchy (Ancestors)

Physical PhenomenaHyperthermia, InducedTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

April 22, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 9, 2015

Record last verified: 2014-10

Locations

TW(1)