Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer

NCT ID: NCT01670409

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-08-31

Brief Summary

The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.

Detailed Description

Esophageal cancer is one of the most common malignant diseases in China, especially in Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per fraction generally. However, although with such comprehensive method, noncontrol of local disease or recurrence is still the main reason of failure.

Most patients with esophageal cancer suffer from malnutrition. A number of factors including hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local failures of disease after treatment; therefore a higher radiation biological equivalent dose (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial had shown that simply increasing total radiation dose could not gain better local control or overall survival rate, however, the ability of this trial to test the potential benefits of higher radiation dose could be compromized by the deficiencies within them, such as, observation bias,large radiated target volume and usage of conventional radiation technique. In other words, the probability that increasing radiation may help improving the control of disease should not be denied.

Modern radiation techniques, such as intensity modulation radiation therapy (IMRT), specially, are able to improve the coverage of target volumes and sparing of critical structures, while increase the total radiation dose. By using simultaneous modulated accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per fraction could be reduced significantly, while the doses to tumor could be increased to higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with conventional technique.

Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late toxicities would be tolerable and slighter than that of conventional technique.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SMART combined with PF chemotherpay

SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)

Group Type: EXPERIMENTAL

SMART

Intervention Type: RADIATION

The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.

PF

Intervention Type: DRUG

Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.

Interventions

SMART

The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.

Intervention Type: RADIATION

PF

Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.

Intervention Type: DRUG

Other Intervention Names

cisplatin plus 5fluorouracil

Eligibility Criteria

Inclusion Criteria

• pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
• the primary disease located in cervical, upper or middle thoracic esophagus
• no distant metastases
• zubrod performance status: 0~2
• life expectancy > 6 months; -absence of another malignancy
• adequate liver, renal and bone marrow function
• women of childbearing potential and male participants must practice adequate contraception
• patient must provide study-specific informed consent prior to study entry

Exclusion Criteria

• evidence of tracheoesophageal or Mediastinal-esophageal fistula
• prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
• prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
• pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• women who are nursing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chuangzhen Chen

OTHER

Sponsor Role: lead

Responsible Party

Chuangzhen Chen

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chuangzhen Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital, Shantou University Medical College

Locations

Cancer Hospital, Shantou University Medical College

Shantou, Guangdong, China

Countries

China

References

Liu W, Zeng C, Wang S, Zhan Y, Huang R, Luo T, Peng G, Wu Y, Qiu Z, Li D, Wu F, Chen C. A combined predicting model for benign esophageal stenosis after simultaneous integrated boost in esophageal squamous cell carcinoma patients (GASTO1072). Front Oncol. 2022 Dec 22;12:1026305. doi: 10.3389/fonc.2022.1026305. eCollection 2022.

Reference Type: DERIVED

PMID: 37078004 (View on PubMed)

Zhang WZ, Chen JZ, Li DR, Chen ZJ, Guo H, Zhuang TT, Li DS, Zhou MZ, Chen CZ. Simultaneous modulated accelerated radiation therapy for esophageal cancer: a feasibility study. World J Gastroenterol. 2014 Oct 14;20(38):13973-80. doi: 10.3748/wjg.v20.i38.13973.

Reference Type: DERIVED

PMID: 25320535 (View on PubMed)

Other Identifiers

ChiCTR-ONC-12002356

Identifier Type: REGISTRY

Identifier Source: secondary_id

SUMC-ECA-001

Identifier Type: -

Identifier Source: org_study_id