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De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04012502
Collaborator
(none)
83
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Toxicities reduced treatment
  • Other: conventional treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
83 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: conventional treatment arm

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
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)
Experimental: Toxicities reduced treatment arm

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
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)

Outcome Measures

Primary Outcome Measures

  1. PFS [2 year]

    Progression Free Survival

Secondary Outcome Measures

  1. OS [2 year]

    Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cannot take contrast-MRI imaging

  • Pregnant

  • Combined with other malignant tumor (except basal cell carcinoma of skin)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan Universtiy Shanghai Cancer Centre Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Chaosu Hu, MD, Fudan University Shanghai cancer centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chaosu Hu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier:
NCT04012502
Other Study ID Numbers:
  • 2019-OR001
First Posted:
Jul 9, 2019
Last Update Posted:
Jul 9, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Oropharyngeal Neoplasms

Study Results

No Results Posted as of Jul 9, 2019