Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Concurrent chemoradiation will consist of hypofractionated intensity modulated radiation therapy (IMRT) with simultaneous integrated boost (SIB) for 3 weeks with carboplatin and paclitaxel for 3 cycles every 7 days. Endoscopy and (optional) PET/CT within 6-8 weeks post-completion of chemoradiation.

Intensity Modulated Radiation Therapy

The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

MD Anderson Symptom Inventory (MDASI)-Plus module

EuroQol (EQ-5D)

SF-12

MOS Social Support Measure

CES-D

-Collected at pre-treatment, every 2 weeks during chemoradiation, every 2-3 weeks during consolidation chemotherapy, completion of therapy, 6-8 week follow-up, 3 month follow-up, 6 month follow-up, and 12 month follow-up

Blood for ctDNA (optional)

-Collected at pre-treatment, completion of therapy, and 6 month follow-up

Blood for SCCA

Gregory Vlacich, M.D., Ph.D.

Aadel Chaudhuri, M.D., Ph.D.

Haeseong Park, M.D., M.P.H.

Cliff Robinson, M.D.

Hyun Kim, M.D.

Lauren Henke, M.D.

Olga Green, Ph.D.

Matt Spraker, M.D.

Yi Huang, Ph.D.

Carmen Bergom, M.D., Ph.D.

Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the original primary cancer. Salvage therapy options are largely ineffective and nearly all patients who develop local disease recurrence will succumb to their cancer. Recent clinical trials for lung cancer have demonstrated that local tumor control can be improved safely with accelerated hypofractionated radiation therapy regimens in order to achieve radiation dose intensification. This clinical trial aims to adapt those techniques and assess the safety of such a regimen for the treatment of inoperable thoracic esophageal cancers.

Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

Phase I Study of Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

The MTD of the combination of radiation and FOLFOX will be estimated using the proposed TITE-CRM model. After the phase I study, the MTD will be chosen as the dose that yields a posterior toxicity estimate closest to 20% while being between 15% and 25%. Toxicity will be coded using CTCAE v5.0.

-The length of time after treatment ends that the participants survives without any signs or symptoms of the cancer recurring within the radiated field

-The length of time from the start of treatment that participants are still alive

-The length of time from the start of treatment to progression or death from any cause

* The MDASI-plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory, ranking their symptoms on a 0 (no problems) to 10 (worst imaginable) scale
* The mean of the scores will be calculated at each time point and compared to other time points to assess changes in cancer-related symptoms

* standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities
* The first part asks respondents to "check the ONE box \[next to the appropriate statement\] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state
* Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state

* 12-item questionnaire measuring physical and mental functional status
* Mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life

-19 items

-. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed with higher scores indicating a greater availability of social support.

* 4 item screening version to evaluate depressive symptoms
* The mean of the scores will be calculated at each time point and compared to other time points to assess changes in depression symptoms

Spots Global Cancer Trial Database for mos social support measure