High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

NCT03936179 | Unknown

• 1 other identifier: SGH201921
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival rate

  survival time was measured from the date of study enrollment to the date of death or last follow-up

  one year

Secondary Outcomes (1)

• acute and late toxicities

  1 year

Study Arms (1)

high dose radiochemotherapy

EXPERIMENTAL

A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy

Radiation: high dose radiation therapy with concurrent chemotherapy

Interventions

high dose radiation therapy with concurrent chemotherapy RADIATION

standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT

high dose radiochemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have FDG-avid and histologically or cytologically proven esophageal cancer.
• Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
• Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2 No prior radiation to the thorax that would overlap with the current treatment field.
• Patients with nodal involvement are eligible
• Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/ mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</ =1 .5 times ULN.
• A signed informed consent must be obtained prior to therapy.
• No prior radiation to the thorax that would overlap with the current treatment field.
• Induction chemotherapy is allowed.

You may not qualify if:

• The presence of a fistula.
• Prior radiotherapy that would overlap the radiation fields.
• gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall.
• Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
• Known hypersensitivity to paclitaxel.
• Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
• Acquired Immune Deficiency Syndrome.
• Conditions precluding medical follow-up and protocol compliance

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tingfeng Chen, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Ningning Cheng, MD

CONTACT

377985364; ningcnn@163.com

Yong Liu, MD

CONTACT

37795364; drliuyrt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director,department of radiation therapy

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: August 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: April 1, 2022
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)