Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 11:44 AM
Study NCT ID:
NCT03981068
Status:
UNKNOWN
Last Update Posted:
2020-09-25
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DAHANCA 37. Re-irradiation With Proton Radiotherapy
Sponsor:
Danish Head and Neck Cancer Group
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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)
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)
Detailed Description:
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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: