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Radiation Dose Escalation in Esophageal Cancer

NCT ID: NCT03082586

Last Updated: 2020-12-22

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-20

Study Completion Date

2018-02-20

Brief Summary

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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.

Detailed Description

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The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

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radiochemotherapy 1

Patients will be treated with radiation therapy 57.2 Gy.

Group Type EXPERIMENTAL

radiochemotherapy 1

Intervention Type 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

radiochemotherapy 2

Patients will be treated with radiation therapy 64.4 Gy.

Group Type EXPERIMENTAL

radiochemotherapy 2

Intervention Type 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

radiochemotherapy 3

Patients will be treated with radiation therapy 71.6 Gy.

Group Type EXPERIMENTAL

radiochemotherapy 3

Intervention Type 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

radiochemotherapy 4

Patients will be treated with radiation therapy 78.8 Gy.

Group Type EXPERIMENTAL

radiochemotherapy 4

Intervention Type 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

radiochemotherapy 5

Patients will be treated with radiation therapy 86 Gy.

Group Type EXPERIMENTAL

radiochemotherapy 5

Intervention Type 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;

radiochemotherapy 6

Patients will be treated with radiation therapy 93.2 Gy.

Group Type EXPERIMENTAL

radiochemotherapy 6

Intervention Type 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

Interventions

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radiochemotherapy 1

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

Intervention Type RADIATION

radiochemotherapy 2

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

Intervention Type RADIATION

radiochemotherapy 3

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

Intervention Type RADIATION

radiochemotherapy 4

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

Intervention Type RADIATION

radiochemotherapy 5

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;

Intervention Type RADIATION

radiochemotherapy 6

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

Intervention Type RADIATION

Other Intervention Names

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concurrent chemoradiotherapy regimen concurrent chemoradiotherapy regimen concurrent chemoradiotherapy regimen concurrent chemoradiotherapy regimen concurrent chemoradiotherapy regimen concurrent chemoradiotherapy regimen

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed primary squamous cell carcinoma of the esophagus
2. Age 1 8-75.
3. Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
4. Patients with distant metastasis and life expectancy \>/= 3 months are eligible.
5. Zubrod performance status 0 to 2
6. No prior radiation to the thorax that would overlap with the current treatment field.
7. Patients with nodal involvement are eligible
8. 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.
9. A signed informed consent must be obtained prior to therapy. 1 0. Induction chemotherapy is allowed.

Exclusion Criteria

1. The presence of a fistula.
2. Prior radiotherapy that would overlap the radiation fields.
3. gastroesophageal junction cancer.
4. 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.
5. Known hypersensitivity to paclitaxel.
6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
7. Acquired Immune Deficiency Syndrome.
8. Conditions precluding medical follow-up and protocol compliance
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chen tingfeng

Director,department of radiation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tingfeng Chen, MD

Role: PRINCIPAL_INVESTIGATOR

the ethic committee of shanghai genernal hospital

Locations

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the Ethic Committee of Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 10235156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1584260 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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SGH201705

Identifier Type: -

Identifier Source: org_study_id