NCT01731548

Brief Summary

We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

12.5 years

First QC Date

November 14, 2012

Last Update Submit

January 21, 2013

Conditions

Carcinoma of LungSmall CellLimited Stage

Outcome Measures

Primary Outcomes (1)

  • local-regional progression

    at least 6 months

Secondary Outcomes (1)

  • overall survival

    at least 1 year

Study Arms (2)

study arm

EXPERIMENTAL

For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）

Radiation: hyperfractionated radiation therapy for both arms

control arm

ACTIVE COMPARATOR

For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).

Radiation: hyperfractionated radiation therapy for both arms

Interventions

hyperfractionated radiation therapy for both armsRADIATION

1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

control armstudy arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage
  • Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.
  • The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.
  • Karnofsky performance status was ≥ 80.
  • Forced expiratory volume at 1 second (FEV1) ≥ 1 L.
  • Had measurable or assessable disease.
  • Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.
  • Serum creatine and bilirubin \< 1.5 × the upper normal limit (UNL), aminotransferase \< 2 × UNL.
  • Weight loss was less than 10% within 6 months before diagnosis.
  • Written informed consent was required from all patients.

You may not qualify if:

  • Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ming Chen, MD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Chen, MD

CONTACT

+86 18758875572gzcm@263.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 21, 2012

Study Start

June 1, 2002

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

CN(1)