Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Head and Neck Neoplasms

All Drugs and Chemicals

Antibodies

Immunoglobulins

Injection; dosage form: 6ml: 240mg; frequency: 240mgQ3W; duration: 17cycles (12 months) or randomization to the date of the first documented progression

Toripalimab

Shengjin Dou

This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate the efficacy and safety of adjuvant Toripalimab in high-risk recurrent/secondary HNSCC after salvage surgery.

High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery(RePASS)

High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery: The RePASS Study

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 1 year

from date of enrollment until date of death from any cause, assessed up to 1 year

from date of enrollment until date of first documented local-regional recurrence or death from any cause, assessed up to 1 year

from date of enrollment until date of first documented distant metastasis or death from any cause, assessed up to 1 year

The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.0 from the date of enrollment to 90 days after last dose of study treatment

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Antineoplastic Agents

Anti-Infective Agents

Cisplatin

Nimorazole

Antiprotozoal Agents

Antiparasitic Agents

60 Gy in 50 fraktions, 10 weekly with protons

Cisplatin for all eligible patients, nimorazole for all SCC

Re-irradiation

Kenneth Jensen, PhD

Jesper Eriksen, Professor

Kenneth Jensen, Ph.D.

Dorte Winther, Nurse

Kenneth Jensen

Summary Design Phase II observational

Treatment

* 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx

  o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
* Proton radiotherapy
* Concomitant cisplatin for eligible patients\*
* Nimorazole recommended for SCC\* \*The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.

Endpoints

* Primary:

  o Any new late toxicity grade \>=3 according to CTC AE 5.0
* Secondary

  * Side effects according to DAHANCA scoring system
  * Quality of life and PROM according to EORTC C30 and HN43
  * Loco-regional control (LRC)
  * Overall survival (OS)

Summary Design Phase II observational Inclusion criteria

* Histological verified loco-regional recurrence or new primary
* Available dose plan from primary radiotherapy course
* Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
* Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy
* Complete Response (CR)\* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
* Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
* Absence of distant metastasis at both

  * clinical examination AND
  * PET-CT or CT of thorax and upper abdomen
* Life expectancy due to age and co-morbidity of \>=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
* PS\<=2 (WHO See appendix)
* The patients should be able to read Danish in order to participate with quality of life questionnaires, but can participate in the rest of the protocol without being fluent in Danish, if capable of reading the patient information.

  \* Complete Response is defined as the situation when a trained clinician, ideally at a multidisciplinary team conference, defines the patient as in complete remission, based on clinical examination and available imaging. This status can of course later be considered wrong as new information becomes available (sub-centimeter nodes grow etc.) Exclusion criteria
* Radical surgery (R0) and absence of adverse prognostic pathological features
* Lymphoma or malignant melanoma
* Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
* As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.

Treatment

* 60 Gy/50 fx / 10W-1 at 1.2 Gy/fx

  o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
* Proton radiotherapy
* Concomitant cisplatin for eligible patients\*
* Nimorazole recommended for SCC\* \*The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.

Endpoints

* Primary:

  o Any new late toxicity grade \>=3 according to CTC AE 5.0
* Secondary

  * Side effects according to DAHANCA scoring system
  * Quality of life and PROM according to EORTC C30 and HN43
  * Loco-regional control (LRC)
  * Overall survival (OS)

Derived projects

* Morbidity (NTCP) modeling for cumulative doses
* Metrics for uncertainties regarding cumulative doses

DAHANCA 37. Re-irradiation With Proton Radiotherapy

DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer

EORTC QLQ HN43 , swallowing scale. Difference (mean) between baseline and 6 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery(RePASS)	NCT04126460	Head and Neck C...	Toripalimab	18 Years -	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
DAHANCA 37. Re-irradiation With Proton Radiotherapy	NCT03981068	Head and Neck N...	Re-irradiation	18 Years -	Danish Head and Neck Cancer Group

Spots Global Cancer Trial Database for second primary