1500 mg durvalumab (MEDI4736) via IV infusion Q4W <<for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48>> or <<until confirmed disease progression>> unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Esophageal Squamous Cell Carcinoma

Durvalumab (MEDI4736) will be supplied as a 500-mg vial solution for infusion after dilution.

Durvalumab

Instituto do Câncer do Estado de São Paulo

Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

Durvalumab (MEDI4736) as Maintenance Treatment Following Chemoradiation for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (DESC).

The primary endpoint is the percentage of subjects who remain progression free at 6 months using investigator assessments according to RECIST 1.1

Incidence of grade 3 or higher toxicities graded according to NCI CTCAE (version 5.0)

Time from randomization until death from any cause.

Defined as the number of patients whose the first site of progression was in field.

Defined as the number of patients whose the first site of progression was distant.

Percentage of subjects who remain progression free at 6 months according to immune-related or response-related markers by immunohistochemistry (PD-1, PD-L1, CTLA-4, CD3, CD4, CD8, CD45RO, forkhead box P3, granzyme B, OX40, cleaved caspase 3 and Ki67).

Tiago Biachi

Principal Investigator

18F-MISO PET/CT -guided dose escalation chemoradiotherapy. All patients were given concurrent chemoradiotherapy within two weeks of diagnosis. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) IMRT technique in the dose-escalation treatment arms. Concurrent chemotherapy consisted of cisplatin (20mg / m2 ,iv, d1- 4) and docetaxel (75mg / m2, d1, d8) administered on the 1st and 4th week of treatment. All patients received adjuvant chemotherapy that ranged from 2 to 4 cycles.

18F-FDG PET/CT -guided dose escalation chemoradiotherapy. All patients were given concurrent chemoradiotherapy within two weeks of diagnosis. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) IMRT technique in the dose-escalation treatment arms. Concurrent chemotherapy consisted of cisplatin (20mg / m2 ,iv, d1- 4) and docetaxel (75mg / m2, d1, d8) administered on the 1st and 4th week of treatment. All patients received adjuvant chemotherapy that ranged from 2 to 4 cycles.

contrast-enhanced CT -guided dose escalation chemoradiotherapy . GTVs were delineated based on fusing diagnostic CT images with simulation CT images.All patients were given concurrent chemoradiotherapy within two weeks of diagnosis. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) IMRT technique in the dose-escalation treatment arms. Concurrent chemotherapy consisted of cisplatin (20mg / m2 ,iv, d1- 4) and docetaxel (75mg / m2, d1, d8) administered on the 1st and 4th week of treatment. All patients received adjuvant chemotherapy that ranged from 2 to 4 cycles.

Nasopharyngeal Carcinoma

Fluorine-18-labeled fluoromisonidazole PET/CT-guided dose escalation chemoradiotherapy (group C). Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy.

FMISO-PET/CT

18F-FDG PET/CT -guided dose escalation chemoradiotherapy. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy.

FDG-PET/CT

contrast-enhanced CT -guided dose escalation chemoradiotherapy. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy

contrast-enhanced CT

Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal Carcinoma

Clinical Feasibility Study of Hypoxia Imaging -Guided IMRT on the Individualized Radiotherapy of Nasopharyngeal Carcinoma

LPF was defined as the time from the date of radiotherapy to local progression in the five years after treatment.Durations were calculated from the end of treatment.

DFS was defined as the time from the date of radiotherapy to recurrence or local progression in the five years after treatment.Durations were calculated from the end of treatment.

OS was defined as the time from the date of radiotherapy to death or the latest date known to be alive. Durations were calculated from the end of treatment.

Acute toxicities were mucositis, nausea/vomiting, arrest of bone marrow, skin desquamation.
Radiotherapy-related toxicities were graded according to the Acute and the Late Radiation Morbidity Scoring Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Chemotherapy-related toxicities (except nausea or alopecia) were graded by the criteria of the WHO.

Late toxicities were skin dystrophy, subcutaneous fibrosis, xerostomia, and hearing loss.
Radiotherapy-related toxicities were graded according to the Acute and the Late Radiation Morbidity Scoring Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Chemotherapy-related toxicities (except nausea or alopecia) were graded by the criteria of the WHO.

Longzhen Zhang

MD,Professor

Xuzhou Medical University

University of North Carolina, Chapel Hill

a compression headband, placed only at the time of irradiation

Alopecia

commercially available office rubber bands (Alliance® Sterling Rubber Bands, Size 105) OR commercially available medical non-latex bands (Allegience® 1" x 18" x .025") with Velcro adhesion
Plastics disks, hollow (3.5 cm diameter, by 1 cm height)
Two bands will be placed just behind the ears laterally, and over the occipital protuberance posteriorly. The plastic inserts will be placed in the temporal fossae bilaterally, under the band to provide adequate tension on the temporal artery.

Compression HeadBand

Dept. of Radiation Oncology, University of Rochester, Med Center

Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

The primary outcome of this study will be the presence of "significant hair loss" by 6 weeks after the completion of whole brain radiation. This will be defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.
The amount of hair loss will be evaluated at the following time points.
Before whole brain radiation
six weeks following radiation

Does a temporary compression headband cause side effects in patients undergoing whole brain ? Nausea? Headache? Redness? Tingling?

If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?

In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?

Researchers can contact the PI to obtain IPD with collaboration.

Michael Milano, MD,PhD

Assoc Professor, Radiation Oncology

This is a Phase 1 dose escalation with an expanded cohort that will enroll at MTD.

Solid Tumors

Pazopanib 800 mg daily TH-302 IV on Days 1, 8, 15 at MTD Subjects will receive this regimen until disease progression.

Pazopanib and TH-302

Duke Cancer Institute

Dose Escalation Study of Pazopanib Plus TH-302

Phase I Dose Escalation of Pazopanib Plus TH-302 in Advanced Solid Tumors

To define the maximal tolerated dose (if any) and the recommended phase II doses for the combination of pazopanib plus TH-302 in patients with advanced solid tumors

To describe any dose limiting and non dose-limiting toxicities of this drug combination

alopecia/hypoxie

Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal Carcinoma

Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Dose Escalation Study of Pazopanib Plus TH-302

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