Radiation Dose Escalation in Esophageal Cancer

NCT03082586 | Completed Results DMC

• 1 other identifier: SGH201705
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP \& Paclitaxel) in patients with inoperable or medically unresectable esophageal cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Dose Limiting Toxicities (DLTs) Occurring in Participants

  The DLTs were defined as grade \>/=4 esophatitis, any other grade \>/=3 nonhematological toxicity (except nausea and vomiting), or grade \>/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.

  15 months

Secondary Outcomes (1)

• Local Failure

  15 months

Study Arms (6)

radiochemotherapy 1

EXPERIMENTAL

Patients will be treated with radiation therapy 57.2 Gy.

Radiation: radiochemotherapy 1

radiochemotherapy 2

EXPERIMENTAL

Patients will be treated with radiation therapy 64.4 Gy.

Radiation: radiochemotherapy 2

radiochemotherapy 3

EXPERIMENTAL

Patients will be treated with radiation therapy 71.6 Gy.

Radiation: radiochemotherapy 3

radiochemotherapy 4

EXPERIMENTAL

Patients will be treated with radiation therapy 78.8 Gy.

Radiation: radiochemotherapy 4

radiochemotherapy 5

EXPERIMENTAL

Patients will be treated with radiation therapy 86 Gy.

Radiation: radiochemotherapy 5

radiochemotherapy 6

EXPERIMENTAL

Patients will be treated with radiation therapy 93.2 Gy.

Radiation: radiochemotherapy 6

Interventions

radiochemotherapy 1 RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen

radiochemotherapy 1

radiochemotherapy 2 RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen

radiochemotherapy 2

radiochemotherapy 3 RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen

radiochemotherapy 3

radiochemotherapy 4 RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen

radiochemotherapy 4

radiochemotherapy 5 RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;

Also known as: concurrent chemoradiotherapy regimen

radiochemotherapy 5

radiochemotherapy 6 RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen

radiochemotherapy 6

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.
• Patients with distant metastasis and life expectancy \>/= 3 months are eligible.
• Zubrod 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. 1 0. 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.
• 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)

the Ethic Committee of Shanghai General Hospital

Shanghai, Shanghai Municipality, 210000, China

Location

Related Publications (2)

• 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 BACKGROUND

• 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

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr tingfeng Chen
• Organization: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

tingfeng138138@163.com

86-021-37798364

Study Officials

• Tingfeng Chen, MD

  the ethic committee of shanghai genernal hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,department of radiation

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: November 20, 2016
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: December 22, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)