High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

NCT03535207 | Unknown

• 1 other identifier: SGH201802
• 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 locoregionally advanced 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)

• toxicities

  1 year

Study Arms (1)

high dose chemoradiotherapy

EXPERIMENTAL

all eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks，followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy

Radiation: high dose chemoradiotherapy

Interventions

high dose chemoradiotherapy RADIATION

Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy after high dose chemoradiation is optional.

high dose chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary squamous cell carcinoma of the esophagus
• Age 1 8-75.
• 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.
• 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 Genernal Hospital

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

Related Publications (2)

• Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.

  PMID: 1584260 BACKGROUND

• Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.

  PMID: 10235156 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Chemoradiotherapy

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)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Tingfeng Chen, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Ningning Cheng

CONTACT

37798364; ningcnn@163.com

Yong Liu, MD

CONTACT

37798364; 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

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 24, 2018
• Study Start: April 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)