Clincosm LogoSign in Get a demo

Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02688036
Collaborator
Sun Yat-sen University (Other), Fudan University (Other), West China Hospital (Other), Zhejiang Cancer Hospital (Other), Tianjin Medical University Cancer Institute and Hospital (Other)
860
Enrollment
1
Location
2
Arms
51
Anticipated Duration (Months)
16.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: hypofractionated concurrent chemoradiotherapy
  • Radiation: conventionally fractionated concurrent chemoradiotherapy
 Phase 3

Detailed Description

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
860 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer
Actual Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: hypofractionated CRT

hypofractionated concurrent chemoradiotherapy

Radiation: hypofractionated concurrent chemoradiotherapy
For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.
Active Comparator: conventionally fractionated CRT

conventionally fractionated concurrent chemoradiotherapy

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

Outcome Measures

Primary Outcome Measures

  1. overall survival [2 years]

Secondary Outcome Measures

  1. disease free survival [2 years]

  2. local-regional failure (Incidence of tumor recurrence in local or regional area) [2 years]

    Incidence of tumor recurrence in local or regional area

  3. toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0) [2 year]

    Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 18~70 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences Beijing China 100021

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: LuHua Wang, MD, Cancer Hospital of CAMS

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Luhua Wang, Vice President of Cancer hospital of CAMS, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02688036
Other Study ID Numbers:
  • CH-L-045/2
First Posted:
Feb 23, 2016
Last Update Posted:
Jan 2, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Luhua Wang, Vice President of Cancer hospital of CAMS, Chinese Academy of Medical Sciences
Limited Disease Small Cell Lung Cancer
concurrent chemoradiotherapy
dose fractionation
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Small Cell

Study Results

No Results Posted as of Jan 2, 2018