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

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A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL) Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC) Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma Weekly Plasma EBV DNA for Non-metastatic Nasopharyngeal Carcinoma Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma MK-2206 in Recurrent Nasopharyngeal Carcinoma Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma Prospective Comparisons of Clinical Trial and Real-world 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Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Effect of Endostar Combined With Intensity-modulated 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Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo 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Brief Title

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

Official Title

De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations

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.

Study Type

Interventional

Primary Outcome

PFS

Secondary Outcome

 OS

Condition

Oropharyngeal Carcinoma

Intervention

Toxicities reduced treatment

Study Arms / Comparison Groups

 conventional treatment arm
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

83

Start Date

July 1, 2019

Completion Date

December 31, 2020

Primary Completion Date

July 1, 2019

Eligibility Criteria

        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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Chaosu Hu, MD, +8618017312903, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04012502

Organization ID

2019-OR001

Responsible Party

Principal Investigator

Study Sponsor

Fudan University

Study Sponsor

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

Verification Date

July 2019