Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Recurrence

Head and Neck Neoplasms

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Oropharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplastic Processes

Disease Attributes

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Cisplatin

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent and adjuvant pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Radiation therapy

Loren Mell, MD

Gerald Henderson

Alysha Zeoli

Ricklie Julian, MD

Khushbu Singh, MBBS, CCRP

Jennifer Pope, CCRP

Melissa Young, MD, PhD

Elisa Lemerond

Jimmy Caudell, MD

Melissa Butler

Douglas Adkins, MD

Aubrey Hamilton

Sarah Wilson

Trisha Wise-Draper, MD, PhD

Kathy Taylor

Mike Gibson, MD

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS).

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)

compare the outcomes with RT/pembrolizumab in patients with tumors as a function of PD-L1 expression.

time from randomization to progression/relapse or death from any cause.

time from randomization to death from any cause

Toxicities due to therapy occurring within 3 months of therapy completion based on CTCAE criteria using questionnaires

Toxicity due to therapy occurring greater than 3 months after completion of therapy based on CTCAE criteria using questionnaires

Local and regional and distant recurrence of cancer and causes of death from competing events

Merck Sharp & Dohme LLC

Director, Division of Clinical and Translational Research/ Department of Radiation Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antoine LEGRAS, MD PhD

Liliane HAMMANI-BERKANI, MSc

Jacques JOUGON, Pr

Bertrand GRAND, Dr

Pascal THOMAS, Pr

Jérome MOUROUX, Pr

Françoise LE PIMPEC-BARTHES, Pr

Pierre MORDANT, Dr

Marco ALIFANO, Pr

Bertrand RICHARD DE LA TOUR, PR

MASSARD Gilbert, Pr

Laurent BROUCHET, Pr

Antoine LEGRAS, Dr

Helene BLONS, PharmD PhD

Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler's regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations.

The French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation.

Thus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery \[1\]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.

We planned a comprehensive molecular characterization of tumors and lymph nodes to evaluate the impact of molecular signatures and molecular heterogeneity on disease-free survival after surgery in IIIA-N2 NSCLC patients. Identification of specific molecular profiles in primary tumors and evolution profiles in nodes might provide clues to the potential risk of metastatic evolution and trigger specific management.

For patients included prospectively, we planned to analyze cell free circulating tumor DNA (ctDNA) as prognostic marker. Because multiple biopsies are not always available in care settings, ctDNA could also be analyzed as a surrogate marker of molecular heterogeneity. Next generation sequencing (NGS) that was validated in our lab to screen ctDNA using a specific bio-informatics workflow allows accurate and cost effective ctDNA screening

Tumor DNA, Tumor RNA, cell free DNA from blood samples

Molecular Signature From Tumor to Lymph Nodes

Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

To identify a molecular signature based on a comprehensive molecular analysis at genomic and transcriptomic levels linked to 3-year disease-free survival in resected IIIA-N2 NSCLC.

To identify a molecular signature based on a comprehensive molecular analysis at genomic and transcriptomic levels linked to 5-year disease-free survival in resected IIIA-N2 NSCLC.

To evaluate the impact of the pathological architectural patterns WHO 2015 classification on the 5-year cancer-specific survival and the 5-year overall survival

To identify tumor molecular patterns associated with specific anatomical lymphatic spread subgroups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer	NCT03383094	Head and Neck S... Cancer Cancer of Head ... Cancer, Advance... Cancer, Metasta... Tumor Tumor Recurrenc... Tumor Neck Tumor Metastasi... Oral Cancer Oropharyngeal C... Oropharynx Canc... Oropharynx Canc... Oropharynx Canc... Oropharynx Canc...	Pembrolizumab Radiation thera... Cisplatin	18 Years -	University of California, San Diego
Molecular Signature From Tumor to Lymph Nodes	NCT04677205	Lung Cancer Stage IIIA-cN2 Operated With C... Primary Tumor T... Node Tumor Tiss...		18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for n2

Every month we try and update this database with for n2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for n2

Every month we try and update this database with for n2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for n2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.