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

Spots Global Cancer Trial Database for A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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