Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Laryngeal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Docetaxel

Tubulin Modulators

Antimitotic Agents

Low dose fractionated radiation - 80cGy with chemotherapy

Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation

Docetaxel and Carboplatin AUC 6

Susanne M Arnold, MD

The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.

A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN

A Phase II Study of Docetaxel, Carboplatin With and Without Low Dose Radiation as Induction Therapy in Locally Advanced Head and Neck Cancer

Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.

To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT. Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): \> 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). (Note: the appearance of one or more new lesions is also considered progression).

Quality of Life (QOL) will be measured pre- and post-treatment using a single 5-question QOL well-being survey. The change in score will be presented independently for each subpart of the QOL survey.

1. Physical; scores range from 7-35; higher scores indicate increased well-being
2. Social/family; scores range from 7-35; higher scores indicate increased well-being
3. Emotional; scores range from 6-30; higher scores indicate increased well-being
4. Functional; scores range from 7-35; higher scores indicate increased well-being
5. Additional Concerns; scores range from 10-50; lower scores indicate increased well-being
6. FACT-G is the sum of the first 4 scores; scores range from 27-135; higher scores indicated increased well-being
7. FACT-H\&N is the sum of the first five scores; scores range from 37-185; higher scores indicated increased well-being
8. Trial Outcome Index is the sum of 1, 4 and 5; scores range from 24-120; higher scores indicated increased well-being

Susanne Arnold

Principal Investigator

Low dose fractionated radiation - 80cGy with chemotherapy

Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT

Chemotherapy Plus Radiation Therapy

Chemotherapy only

Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation

Chemotherapy Without Radiation

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Susanne Arnold

Primary Site Complete Response Rate

Overall Response Rate

PHYSICAL WELL-BEING SCORE

SOCIAL/FAMILY WELL-BEING SCORE

EMOTIONAL WELL-BEING SCORE

FUNCTIONAL WELL-BEING SCORE

FACT-G TOTAL SCORE

ADDITIONAL CONCERNS SCORE

FACT-H&N TOTAL SCORE

TRIAL OUTCOME INDEX SCORE

Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.

3-year Overall Survival

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Combination treatment of low-dose radiation 20cGy every 3 weeks three times and autologous immune cell therapy 2 consecutive weeks 3 times every 3 weeks

InnoLak two consecutive weeks every 3 weeks for 3 times

Immune cell

20cGy whole body radiation every three weeks for three times

Low dose radiation

Sang-Young Ryu, MD

Among the immune cell therapy, autologous adoptive immune cell therapy is a method to transfer the immune cells derived from peripheral white blood cells and expanded and stimulated with various cytokines and tumor specific antigens in cancer patients. Recently, the low-dose radiation is known to increase the immune response in many human cancer patients. In a clinical trial, 70% response rate with combination of low-dose radiation and adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to investigate the feasibility of combination of low-dose radiation and autologous immune cell therapy in recurrent cervical cancer which is resistant to conventional palliative treatment.

Immune cell therapy is considered one of the most promising anti-cancer strategy in many human cancers. Compared to the destructive methods such as surgery, radiation, and chemotherapy, anti-cancer immune therapy is safer and less toxic method in the treatment of human cancer patients.

Among the immune cell therapy, autologous adoptive immune cell therapy is a method to transfer the immune cells derived from peripheral white blood cells and expanded and stimulated with various cytokines and tumor specific antigens in cancer patients. Recent development of the technique to expand immune cells ex vivo make autologous adoptive immune cell therapy much more feasible and popular. However, immune cell therapy showed response of below 10% currently in several clinical trials. The reason of poor response is that the adopted immune cells have to overcome the highly immune compromised environment in advanced or recurrent cancer patients.

The low-dose radiation, defined as the radiation below the therapeutic dose range, is known to increase the immune response in many human cancer patients. Despite the exact mechanism is not well known, the 'danger signal' and the decrease of T-regulatory cells by low-dose radiation are the possible mechanism of enhanced immunity by low-dose radiation. So, the combination of low-dose radiation and immune cell therapy can be a attractive strategy to recurrent or advanced cancer patients who are resistant to conventional treatment.

A challenging clinical trial performed in recurrent melanoma cancers, Dr. Rosenverg reported around 70% response rate with combination of low-dose radiation and adoptive immune cell therapy. However, the feasibility of combination of low-dose radiation and immune cell therapy is still unknown in many human cancers.

This study is to investigate the feasibility of combination of low-dose radiation and autologous immune cell therapy in recurrent cervical cancer which is resistant to conventional palliative treatment. The cervical cancer, highly responsive to radiation, becomes resistant to radiation in case of recurrent disease. We hypothetize that if the low-dose radiation can reverse the immune compromised environment, adoptive immune cells derived from the autologous peripheral blood immune cells will be highly effective in recurrent cervical cancers.

A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer

A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer

Response rate according to RECIST criteria for 12 months

Korea Cancer Center Hospital

A staff at department of obstetrics and gynecology

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

primarily resectable pancreatic cancer patients

neoadjuvant Radiation of 0,5 Gy two days before resection

neoadjuvant Radiation of 2 Gy 2 days before resection

neoadjuvant Radiation of 5 Gy 2 days before resection

single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection

neoadjuvant photon radiation

single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

Peter E. Huber, Prof. PhD MD

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.

Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer

Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity

local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls

surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment

frequencies of tumor-reactive T-cells in blood and bone marrow

expression of migration-relevant adhesion molecules on tumor endothelial cells

expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood

quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months

Heidelberg University

German Cancer Research Center

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.

A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.

A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume.

A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume.

Radiation Therapy

Song W

Noah Kalman, M.D.

Chris McLaughlin, M.D.

Edwin Crandley, M.D.

Shiyu Song, M.D.

The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.

In squamous cell carcinomas of the head and neck, regional recurrence is rare within lymph node stations treated with elective radiation. However, radiotherapy to the neck is toxic, and leads to a variety of unpleasant side effects, especially coupled with concurrent systemic therapy. There is growing evidence from previous studies showing that lower radiation doses may be adequate in preventing locoregional recurrence of disease. The hypothesis is that lower dose of radiation will have equal effectiveness but less toxicity than standard approaches for the treatment of squamous cell carcinomas of the head and neck.

The study evaluates the effectiveness and safety of reduced dose radiotherapy for definitive and adjuvant treatment of Human papillomavirus (HPV) positive oropharyngeal squamous cell carcinomas.

Participants will be treated with a radiation therapy regimen that has a lower dose to less tissue area (dose and volume de-escalation) than standard of care radiation therapy. The dosing will be determined by whether concurrent chemotherapy will be given, results from on treatment HPV blood test called NavDx, physical exam, and imaging. On treatment NavDx results indicating a slow (non-rapid) response to the treatment will receive an additional boost of radiation. Routine NavDx testing will be performed to assess treatment response and recurrence. Participants will also be asked to complete surveys about overall health and wellbeing.

Participants on this study will undergo a reduced dose regimen starting with a boost to gross disease of 24 Gy, then 30-36 Gy to entire volume based on the plan for concurrent chemotherapy. Non-responders will receive a boost to the entire volume for an additional 10 Gy.

HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma

Circulating Tumor Modified HPV DNA-Guided Radiotherapy De-intensification of the Elective Neck (RaDEN) in Squamous Cell Carcinoma of the Head and Neck

Baseline lymphocyte counts from CBC with Differential blood test

Incidence of disease free survival as measured by circulating HPV on Nav Dx blood tests.

Incidence of grade 3 (or greater) adverse events as defined by the CTCAE v5.0

Quality of life as determined by the EORTC H\&N35. Questions are scaled from 1-4 with 1 meaning the symptom/problem was not experienced and 4 meaning the symptom/problem was experienced at a high level.

Quality of life as determined by the EORTC QLQ-C30. Majority of questions are scaled from 1-4 with 1 meaning the symptom/problem was not experienced and 4 meaning the symptom/problem was experienced at a high level. Two questions are scaled from 1-7 with 1 meaning very poor (worse outcome) and 7 meaning excellent (best outcome).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN	NCT02126969	Head and Neck C... Larynx	Low dose fracti... Docetaxel and C...	18 Years -	University of Kentucky
A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer	NCT01194609	Uterine Cervica...	Immune cell Low dose radiat...	18 Years - 75 Years	Korea Cancer Center Hospital
Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer	NCT01027221	Primarily Resec...	neoadjuvant pho... neoadjuvant pho... neoadjuvant pho...	50 Years -	German Cancer Research Center
HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma	NCT05962242	Squamous Cell C...	Radiation Thera...	18 Years -	University of Virginia
HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma	NCT05962242	Squamous Cell C...	Radiation Thera...	18 Years -	University of Virginia

Spots Global Cancer Trial Database for low dose radiation