NCT04012502

Brief Summary

Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

July 4, 2019

Last Update Submit

July 8, 2019

Conditions

Oropharyngeal CarcinomaDe-escalation

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression Free Survival

    2 year

Secondary Outcomes (1)

  • OS

    2 year

Study Arms (2)

conventional treatment arm

ACTIVE COMPARATOR

Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)

Other: conventional treatment

Toxicities reduced treatment arm

EXPERIMENTAL

Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)

Other: Toxicities reduced treatment

Interventions

Toxicities reduced treatmentOTHER

Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)

Toxicities reduced treatment arm
conventional treatmentOTHER

Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)

conventional treatment arm

Eligibility Criteria

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

You may qualify if:

  • Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
  • T1-2/N1-3M0（except T1N1M0 and single LN\<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
  • Age ≥18
  • No prior anti-tumor treatment
  • Karnofsky Performance Score (KPS)≥70
  • Adequate blood supply
  • Informed consent obtained

You may not qualify if:

  • cannot take contrast-MRI imaging
  • Pregnant
  • Combined with other malignant tumor (except basal cell carcinoma of skin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Chaosu Hu, MD

    Fudan University Shanghai cancer centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting xu, MD

CONTACT

+8618017312903dr_tingtingxu@163.com

xueguan Lu, MD

CONTACT

+8618121299382luxueguan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2019

Study Completion

December 31, 2020

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

CN(1)