Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions

September 16, 2020 updated by: Zhejiang Cancer Hospital

The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions

Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
  2. Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
  3. The metastatic lesions ≤5 and metastatic organs ≤2
  4. Karnofsky scores >70
  5. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
  6. Informed consent signed.

Exclusion Criteria:

  1. Histologically conformed initial keratinizing carcinoma or others.
  2. The metastatic lesions >5 or metastatic organs >2.
  3. Any severe complications contraindicated chemotherapy or radiotherapy.
  4. History of malignant tumors.
  5. Pregnant or nursing women.
  6. History of radiotherapy or chemotherpy in head and neck regions.
  7. Patients refused the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy.
Radiation: radical radiotherapy
radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Events of death caused by any reasons
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress free survival
Time Frame: From date of diagnosis until the date of first documented progression, assessed up to 36 months
adverse event including death, recurrence and metastases.
From date of diagnosis until the date of first documented progression, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2017

Primary Completion (Anticipated)

April 23, 2023

Study Completion (Anticipated)

April 23, 2025

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-Oligo-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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