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Carcinoma, Small CellPhase 3NCT02688036

Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

A Phase 3 study testing hypofractionated concurrent chemoradiotherapy and conventionally fractionated concurrent chemoradiotherapy in people with Carcinoma, Small Cell and Lung Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carcinoma, Small Cell, Lung Neoplasms
What is being tested?
hypofractionated concurrent chemoradiotherapy and conventionally fractionated concurrent chemoradiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
860 participants
Where
1 siteChina
Study dates
Feb 2016to Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

Official title: Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer

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.

Read the 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.

Being tested
hypofractionated concurrent chemoradiotherapy, conventionally fractionated concurrent chemoradiotherapy
Keywords
Limited Disease Small Cell Lung Cancer, concurrent chemoradiotherapy, dose fractionation
Medical subject headings
Carcinoma, Small Cell, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hypofractionated concurrent chemoradiotherapyRadiation

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

  • conventionally fractionated concurrent chemoradiotherapyRadiation

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

Study groups in NCT02688036
Study groupRoleWhat they receive
hypofractionated CRTExperimentalhypofractionated concurrent chemoradiotherapy
Receives: Radiation: hypofractionated concurrent chemoradiotherapy
conventionally fractionated CRTActive comparatorconventionally fractionated concurrent chemoradiotherapy
Receives: Radiation: conventionally fractionated concurrent chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 2 years

Secondary outcomes (3)
  1. disease free survival

    Measured: 2 years

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

    Incidence of tumor recurrence in local or regional area

    Measured: 2 years

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

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

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2022
  4. Study completionDec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
860 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02688036
Sponsor's protocol ID
CH-L-045/2
Status last verified
May 2026
First submitted
20 Nov 2015
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.

    PubMed 17008692
  • Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.

    PubMed 1331787
  • Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5. doi: 10.1200/JCO.1992.10.6.890.

    PubMed 1316951
  • Murray N, Coy P, Pater JL, Hodson I, Arnold A, Zee BC, Payne D, Kostashuk EC, Evans WK, Dixon P, et al. Importance of timing for thoracic irradiation in the combined modality treatment of limited-stage small-cell lung cancer. The National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1993 Feb;11(2):336-44. doi: 10.1200/JCO.1993.11.2.336.

    PubMed 8381164
  • Jeremic B, Shibamoto Y, Acimovic L, Milisavljevic S. Initial versus delayed accelerated hyperfractionated radiation therapy and concurrent chemotherapy in limited small-cell lung cancer: a randomized study. J Clin Oncol. 1997 Mar;15(3):893-900. doi: 10.1200/JCO.1997.15.3.893.

    PubMed 9060525
  • Takada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071.

    PubMed 12118018
  • Kubota K, Hida T, Ishikura S, Mizusawa J, Nishio M, Kawahara M, Yokoyama A, Imamura F, Takeda K, Negoro S, Harada M, Okamoto H, Yamamoto N, Shinkai T, Sakai H, Matsui K, Nakagawa K, Shibata T, Saijo N, Tamura T; Japan Clinical Oncology Group. Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy (JCOG0202): a randomised phase 3 study. Lancet Oncol. 2014 Jan;15(1):106-13. doi: 10.1016/S1470-2045(13)70511-4. Epub 2013 Dec 3.

    PubMed 24309370
  • Auperin A, Arriagada R, Pignon JP, Le Pechoux C, Gregor A, Stephens RJ, Kristjansen PE, Johnson BE, Ueoka H, Wagner H, Aisner J. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group. N Engl J Med. 1999 Aug 12;341(7):476-84. doi: 10.1056/NEJM199908123410703.

    PubMed 10441603
  • Carney DN, Mitchell JB, Kinsella TJ. In vitro radiation and chemotherapy sensitivity of established cell lines of human small cell lung cancer and its large cell morphological variants. Cancer Res. 1983 Jun;43(6):2806-11.

    PubMed 6303568
  • Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403.

    PubMed 9920950
  • Movsas B, Moughan J, Komaki R, Choy H, Byhardt R, Langer C, Goldberg M, Graham M, Ettinger D, Johnstone D, Abrams R, Munden R, Starkschall G, Owen J. Radiotherapy patterns of care study in lung carcinoma. J Clin Oncol. 2003 Dec 15;21(24):4553-9. doi: 10.1200/JCO.2003.04.018. Epub 2003 Nov 3.

    PubMed 14597743
  • Salama JK, Hodgson L, Pang H, Urbanic JJ, Blackstock AW, Schild SE, Crawford J, Bogart JA, Vokes EE; Cancer and Leukemia Group B. A pooled analysis of limited-stage small-cell lung cancer patients treated with induction chemotherapy followed by concurrent platinum-based chemotherapy and 70 Gy daily radiotherapy: CALGB 30904. J Thorac Oncol. 2013 Aug;8(8):1043-9. doi: 10.1097/JTO.0b013e318293d8a4.

    PubMed 23715301
  • Gazula A, Baldini EH, Chen A, Kozono D. Comparison of once and twice daily radiotherapy for limited stage small-cell lung cancer. Lung. 2014 Feb;192(1):151-8. doi: 10.1007/s00408-013-9518-9. Epub 2013 Oct 27.

    PubMed 24162870
  • Withers HR, Taylor JM, Maciejewski B. The hazard of accelerated tumor clonogen repopulation during radiotherapy. Acta Oncol. 1988;27(2):131-46. doi: 10.3109/02841868809090333.

    PubMed 3390344
  • Spiro SG, James LE, Rudd RM, Trask CW, Tobias JS, Snee M, Gilligan D, Murray PA, Ruiz de Elvira MC, O'Donnell KM, Gower NH, Harper PG, Hackshaw AK; London Lung Cancer Group. Early compared with late radiotherapy in combined modality treatment for limited disease small-cell lung cancer: a London Lung Cancer Group multicenter randomized clinical trial and meta-analysis. J Clin Oncol. 2006 Aug 20;24(24):3823-30. doi: 10.1200/JCO.2005.05.3181.

    PubMed 16921033

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hypofractionated concurrent chemoradiotherapy and conventionally fractionated concurrent chemoradiotherapy in people with Carcinoma, Small Cell and Lung Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688036, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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