Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Omission of elective nodal irradiation in N0 hemi-neck of well lateralized H\&N SCCs ( pN0 or by PETCT). Dose de-escalation of elective nodal irradiation in N0 hemi-neck of midline H\&N SCCs ( pN0 or by PETCT).

Elective nodal de-escalation arm

Sara A Elsharkawy

May Ashour

Sara Elsharkawy

Tarek Shouman

This is a non-randomized prospective trial evaluating the non- inferiority of de-escalating the volume and/or dose of elective nodal irradiation in post-operative head and neck squamous cell carcinomas.

This is a non-randomized prospective trial evaluating the non-inferiority of volume and/or dose de-escalation of elective nodal irradiation in post-operative head and neck squamous cell carcinomas with assessment of toxicity profiles.

57 head and neck squamous cell carcinoma cases eligible for post-operative radiotherapy will be recruited and managed according to tumor laterality, nodal status, and laterality of nodal dissection (ipsilateral/ bilateral nodal dissection).

Ipsilateral nodal dissection:

* If ipsilateral N0, bilateral nodal irradiation will be omitted.
* If ipsilateral N positive and tumor was well lateralized, contralateral nodal negativity will be assessed by PETCT. IF PETCT is free, the ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be omitted.
* If ipsilateral N positive and tumor was not well lateralized, ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
* Cases with PETCT positive for malignancy will be excluded from the study.

Bilateral nodal dissection:

* If bilateral N0, bilateral nodal irradiation will be omitted.
* If one sided N positive, laterality of the tumor will be assessed:

  * In well lateralized tumors, the positive side nodal regions will be irradiated while the contralateral nodal irradiation will be omitted.
  * In midline/ non lateralized tumor the positive side nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
* If bilateral N positive, cases will be excluded from the study.

Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma

National Cancer Institute, Egypt

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Pancreatic Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Melanoma

Esophageal Squamous Cell Carcinoma

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Esophageal Neoplasms

Esophageal Diseases

Pancreatic Cancer

Neuroendocrine Tumor

Neuroepithelioma

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

LGK974

Spartalizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Enzyme Inhibitors

PDR001

Novartis Pharmaceuticals

The primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies that have progressed despite standard therapy or for which no effective standard therapy exists

This open-label multicenter phase 1 dose escalation study will be the first to administer LGK974 as a single agent or in combination with PDR001 in humans.

The study will comprise of 2 parts: a dose escalation of LGK974 as a single agent, followed by a safety expansion in specific disease indications; and a dose escalation of LGK974 in combination with PDR001, followed by a safety expansion in cutaneous melanoma.

A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands

Determine the Maximum Tolerated Dose (MTD) or Recommended Dose for Expansion (RDE) of LGK974 as a single agent and in combination with PDR001 when administered orally to adult patients with malignancies dependent on Wnt ligands.

The incidence of treatment-emergent adverse events (new or worsening from baseline) will be summarized by primary system organ class, severity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, type of AE, relationship to study drug by dose group.

Evaluate pharmacokinetic (PK) parameters such as AUClast, AUCtau, Cmax, the apparent elimination T1/2 and Racc for LGK974 and its pharmacologically metabolite.

Assessing percent change from baseline to post-treatment of PD related to the Wnt pathway.

Patients with an Overall Response Rate(ORR), complete response (CR) or partial response (PR) rate and duration of response (DOR) assessed by RECIST 1.1 for single agent LGK974 and by RECIST1.1 and irRC for LGK974+PDR001.

Evaluate pharmacokinetic (PK) parameters such as AUClast, AUCtau, Cmax, the apparent elimination T1/2 and Racc for LGK974, its pharmacologically metabolite and PDR001.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma	NCT05650034	Head and Neck C...	Elective nodal ...	18 Years - 78 Years	National Cancer Institute, Egypt
A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands	NCT01351103	Pancreatic Canc... BRAF Mutant Col... Melanoma Triple Negative... Head and Neck S... Cervical Squamo... Esophageal Squa... Lung Squamous C...	LGK974 PDR001	18 Years -	Novartis
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma	NCT05650034	Head and Neck C...	Elective nodal ...	18 Years - 78 Years	National Cancer Institute, Egypt
A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands	NCT01351103	Pancreatic Canc... BRAF Mutant Col... Melanoma Triple Negative... Head and Neck S... Cervical Squamo... Esophageal Squa... Lung Squamous C...	LGK974 PDR001	18 Years -	Novartis

Spots Global Cancer Trial Database for head and neck scc