Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

NCT02688036 | Unknown Phase 3

• 1 other identifier: CH-L-045/2
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.

Conditions

Carcinoma, Small Cell; Lung Neoplasms

Keywords

Limited Disease Small Cell Lung Cancer; concurrent chemoradiotherapy; dose fractionation

Outcome Measures

Primary Outcomes (1)

• overall survival

  2 years

Secondary Outcomes (3)

• disease free survival

  2 years

• local-regional failure (Incidence of tumor recurrence in local or regional area)

  2 years

• toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)

  2 year

Study Arms (2)

hypofractionated CRT

EXPERIMENTAL

hypofractionated concurrent chemoradiotherapy

Radiation: hypofractionated concurrent chemoradiotherapy

conventionally fractionated CRT

ACTIVE COMPARATOR

conventionally fractionated concurrent chemoradiotherapy

Radiation: conventionally fractionated concurrent chemoradiotherapy

Interventions

hypofractionated concurrent chemoradiotherapy RADIATION

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.

hypofractionated CRT

conventionally fractionated concurrent chemoradiotherapy RADIATION

For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.

conventionally fractionated CRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~70 years old, ECOG 0-2
• patients with histologically or cytologically proved small cell lung cancer
• Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition.
• No progression after 2 cycles of chemotherapy with EP.
• No prior history of anti-tumor treatment.
• No severe internal diseases and no organ dysfunction
• Written informed consent provided and

You may not qualify if:

• Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
• Active heart disease or acute myocardial infarction happen in six months.
• Psychiatric history.
• Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
• Uncontrolled diabetes or hypertension
• Interstitial pneumonia or Active pulmonary fibrosis
• Acute bacterial or fungal infection
• Oral or intravenous use of steroids

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Sun Yat-sen University: collaborator
• Fudan University: collaborator
• West China Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Small Cell; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• LuHua Wang, MD

  Cancer Hospital of CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LuHua Wang, MD

CONTACT

861087788799; wlhwq@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Cancer hospital of CAMS

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: February 23, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)